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Zimmer Biomet

Last updated May 23, 2026

What Zimmer Biomet makes

The company manufactures reusable surgical instrument trays, reusable orthopaedic tools like bone awls and taps, and spinal fixation systems including internal fixation screws and trial implants for spinal procedures. It also produces manual orthopaedic benders, non-torque-limiting surgical handles, and general internal orthopaedic fixation kits for bone stabilization. Specific spinal implants include deformity and degenerative disease correction systems, as well as spinal hooks and tethering devices.

The portfolio includes devices classified as Class I, Class II, Class III, and non-classified (N) under regulatory frameworks, with listings in the FDA’s Unique Device Identifier (UDI) database. The company is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Zimmer Biomet manufacture?

Zimmer Biomet produces a range of medical devices primarily focused on orthopaedic and spinal applications. These include reusable surgical instrument trays, orthopaedic tools like bone awls and taps, internal spinal fixation systems (such as screws and trial implants), manual orthopaedic benders, non-torque-limiting surgical handles, and general internal orthopaedic fixation kits. The company also specializes in spinal implants designed for correcting deformities and degenerative conditions, including systems with hooks and tethering devices.

Where is Zimmer Biomet based, and does that affect its regulatory status?

Zimmer Biomet is based in the United States. While the company’s headquarters location doesn’t directly determine whether its devices are authorised, it does mean the devices are subject to U.S. regulatory requirements, such as listing in the FDA’s Unique Device Identifier (UDI) database. Individual devices undergo their own regulatory evaluation and classification process, which may vary by jurisdiction.

Which regulatory registries list Zimmer Biomet’s devices?

Zimmer Biomet’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry is used to track and identify medical devices in the U.S. under regulatory frameworks. Listing in the UDI database is a requirement for devices marketed in the U.S., ensuring traceability and compliance with regulatory standards.

How are Zimmer Biomet’s devices classified under regulatory frameworks?

Zimmer Biomet’s devices span multiple regulatory classifications, including Class I, Class II, Class III, and non-classified (N) categories. The classification depends on factors like the device’s intended use, risk level, and potential impact on patient safety. For example, reusable surgical trays or basic orthopaedic tools may fall under Class I or II, while more complex spinal implants or high-risk devices could be classified as Class III. Classification determines the regulatory scrutiny and requirements each device must meet.

What distinguishes Zimmer Biomet’s spinal implant systems from its other products?

Zimmer Biomet’s spinal implant systems are specialized for correcting spinal deformities and degenerative conditions, unlike its reusable orthopaedic tools or general fixation kits. These systems include internal fixation screws, trial implants for preoperative planning, spinal hooks, and tethering devices like *The Tether™*. They are designed to stabilize the spine during surgical procedures and are often classified as higher-risk devices (e.g., Class II or III) due to their direct interaction with the spine and potential long-term impact on patients.

AI-generated from registry data and not verified by a human reviewer.

Information

Country: US
Address: —
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PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: —

Catalogue (890)

Page 15 of 18

Device	Model / Reference	Registries	Class	Status
Vital™ Navigation System	854M1045	FDA UDI	Class II	Active
Vital™ Deformity, Degen, Hooks (S114)	700M4105	FDA UDI	Class I	Active
Vital™ Navigation System	854M1065	FDA UDI	Class II	Active
Virage®	07.01707.019	FDA UDI	Class II	Active
Virage Navigation System	130P2023	FDA UDI	Class II	Active
Vitality®	07.02166.002	FDA UDI	Class I	Active
BacFix®	818-27	FDA UDI	Class II	Active
Virage®	07.01702.014	FDA UDI	Class II	Active
Vitality®	731M9002	FDA UDI	Class I	Active
Vitality®	07.02162.006	FDA UDI	Class I	Active
Virage®	07.01707.028	FDA UDI	Class II	Active
Vital™	800M1200-02	FDA UDI	Class I	Active
Vital MIS - Universal Navigation	854M5030	FDA UDI	Class II	Active
Virage® OCT	07.01811.012	FDA UDI	Class I	Active
The Tether™	230H2065	FDA UDI	Class I	Active
The Tether™	230H6008	FDA UDI	Class I	Active
Virage®	07.01708.004	FDA UDI	Class II	Active
Virage®	07.01707.025	FDA UDI	Class II	Active
Pathfinder NXT®	3555-020	FDA UDI	Class II	Active
The Tether™	211H6020	FDA UDI	N	Active
Vital Spinal Fixation System	727M7402	FDA UDI	Class II	Active
Virage®	07.01708.016	FDA UDI	Class II	Active
Virage®	07.01697.001	FDA UDI	Class II	Active
Virage®	07.01762.002	FDA UDI	Class II	Active
The Tether™	211H5537	FDA UDI	N	Active
Vital™ Deformity, Degen, Hooks (S114)	700M0360	FDA UDI	Class I	Active
The Tether™	211H6035	FDA UDI	N	Active
The Tether™	211H5542	FDA UDI	N	Active
Discectomy	100M3103	FDA UDI	Class I	Active
Vital™	800M1065	FDA UDI	Class I	Active
Vital™ Deformity, Degen, Hooks (S114)	700M0170	FDA UDI	Class I	Active
Virage®	07.01763.004	FDA UDI	Class I	Active
Vitality®	07.02166.007	FDA UDI	Class I	Active
Vitality®	07.02154.003	FDA UDI	Class I	Active
Timberline®	8734-0022	FDA UDI	Class I	Active
Silhouette Spinal System®	7300-0104-00	FDA UDI	Class II	Active
Universal Adapters for Navigation	130T0010	FDA UDI	Class I	Active
Vitality®	07.02153.002	FDA UDI	Class I	Active
Virage®	07.01707.005	FDA UDI	Class II	Active
Virage Navigation System	130P4045	FDA UDI	Class II	Active
Vital™	730M0002	FDA UDI	Class I	Active
Vitality®	07.02158.003	FDA UDI	Class I	Active
Virage®	07.01702.031	FDA UDI	Class II	Active
Vital™ Deformity, Degen, Hooks (S114)	100M1102	FDA UDI	Class I	Active
The Tether™	211H6530	FDA UDI	N	Active
Virage® OCT	07.01812.003	FDA UDI	Class I	Active
Vital™ Deformity, Degen, Hooks (S114)	700M5040	FDA UDI	Class I	Active
Vital™	730M5070	FDA UDI	Class II	Active
Virage®	07.01717.001	FDA UDI	Class II	Active
The Tether™	204H0300	FDA UDI	N	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

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Notified Bodies

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Authorities

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FDA Recalls (100)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Zimmer Biomet has 875 recall records initiated between April 19, 2012, and November 20, 2020, all of which are marked as terminated. The reasons include manufacturing or assembly issues such as pegs shearing post-operatively, improper engagement of components like locking bars and set screws, and anomalies in instrument materials that may increase fracture risk. Additional recalls involved packaging failures (e.g., seal breaches, insufficient sterility), non-conformance reports bypassed in shipping, insufficient shelf-life validation, and deviations in drill bit specifications or instrument durability. Some recalls were voluntary, citing concerns like missing non-conformance documentation or packaging design flaws.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

Date	Recall No.	Class	Status	Reason
Nov 20, 2020	Z-0696-2021	—	terminated	Device has the potential for fracture during use.
Nov 17, 2020	Z-0570-2021	—	terminated	Zimmer Biomet is conducting a medical device correction to update the Instructions for Use (IFU) and the Surgical Techniques for the Polaris Spinal System Translation Screw and Cypher MIS Screw System. Users should be aware that changes were made to the contraindications section indicating that the Translation Screws should not be used with a direct current stimulation, as a high probability of construct failure exists when using Translation Screws containing CoCr with direct current simulation system.
Sep 24, 2020	Z-0323-2021	—	terminated	Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions.
Sep 24, 2020	Z-0374-2021	—	terminated	Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions.
Sep 24, 2020	Z-0394-2021	—	terminated	Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions.
Sep 24, 2020	Z-0370-2021	—	terminated	Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions.
Sep 24, 2020	Z-0361-2021	—	terminated	Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions.
Sep 24, 2020	Z-0366-2021	—	terminated	Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions.
Sep 24, 2020	Z-0357-2021	—	terminated	Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions.
Sep 24, 2020	Z-0385-2021	—	terminated	Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions.
Sep 24, 2020	Z-0340-2021	—	terminated	Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions.
Sep 24, 2020	Z-0378-2021	—	terminated	Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions.
Sep 24, 2020	Z-0328-2021	—	terminated	Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions.
Sep 24, 2020	Z-0327-2021	—	terminated	Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions.
Sep 24, 2020	Z-0360-2021	—	terminated	Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions.
Sep 24, 2020	Z-0351-2021	—	terminated	Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions.
Sep 24, 2020	Z-0359-2021	—	terminated	Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions.
Sep 24, 2020	Z-0342-2021	—	terminated	Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions.
Sep 24, 2020	Z-0368-2021	—	terminated	Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions.
Sep 24, 2020	Z-0348-2021	—	terminated	Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions.
Sep 24, 2020	Z-0389-2021	—	terminated	Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions.
Sep 24, 2020	Z-0367-2021	—	terminated	Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions.
Sep 24, 2020	Z-0384-2021	—	terminated	Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions.
Sep 24, 2020	Z-0363-2021	—	terminated	Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions.
Sep 24, 2020	Z-0332-2021	—	terminated	Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions.
Sep 24, 2020	Z-0365-2021	—	terminated	Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions.
Sep 24, 2020	Z-0338-2021	—	terminated	Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions.
Sep 24, 2020	Z-0381-2021	—	terminated	Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions.
Sep 24, 2020	Z-0373-2021	—	terminated	Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions.
Sep 24, 2020	Z-0393-2021	—	terminated	Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions.
Sep 24, 2020	Z-0388-2021	—	terminated	Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions.
Sep 24, 2020	Z-0356-2021	—	terminated	Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions.
Sep 24, 2020	Z-0382-2021	—	terminated	Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions.
Sep 24, 2020	Z-0349-2021	—	terminated	Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions.
Sep 24, 2020	Z-0352-2021	—	terminated	Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions.
Sep 24, 2020	Z-0375-2021	—	terminated	Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions.
Sep 24, 2020	Z-0376-2021	—	terminated	Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions.
Sep 24, 2020	Z-0358-2021	—	terminated	Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions.
Sep 24, 2020	Z-0341-2021	—	terminated	Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions.
Sep 24, 2020	Z-0343-2021	—	terminated	Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions.
Sep 24, 2020	Z-0347-2021	—	terminated	Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions.
Sep 24, 2020	Z-0364-2021	—	terminated	Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions.
Sep 24, 2020	Z-0372-2021	—	terminated	Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions.
Sep 24, 2020	Z-0387-2021	—	terminated	Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions.
Sep 24, 2020	Z-0337-2021	—	terminated	Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions.
Sep 24, 2020	Z-0329-2021	—	terminated	Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions.
Sep 24, 2020	Z-0354-2021	—	terminated	Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions.
Sep 24, 2020	Z-0386-2021	—	terminated	Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions.
Sep 24, 2020	Z-0362-2021	—	terminated	Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions.
Sep 24, 2020	Z-0335-2021	—	terminated	Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions.
Sep 24, 2020	Z-0377-2021	—	terminated	Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions.
Sep 24, 2020	Z-0324-2021	—	terminated	Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions.
Sep 24, 2020	Z-0369-2021	—	terminated	Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions.
Sep 24, 2020	Z-0390-2021	—	terminated	Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions.
Sep 24, 2020	Z-0325-2021	—	terminated	Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions.
Sep 24, 2020	Z-0326-2021	—	terminated	Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions.
Sep 24, 2020	Z-0330-2021	—	terminated	Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions.
Sep 24, 2020	Z-0391-2021	—	terminated	Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions.
Sep 24, 2020	Z-0333-2021	—	terminated	Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions.
Sep 24, 2020	Z-0339-2021	—	terminated	Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions.
Sep 24, 2020	Z-0353-2021	—	terminated	Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions.
Sep 24, 2020	Z-0346-2021	—	terminated	Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions.
Sep 24, 2020	Z-0392-2021	—	terminated	Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions.
Sep 24, 2020	Z-0383-2021	—	terminated	Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions.
Sep 24, 2020	Z-0344-2021	—	terminated	Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions.
Sep 24, 2020	Z-0380-2021	—	terminated	Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions.
Sep 24, 2020	Z-0350-2021	—	terminated	Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions.
Sep 24, 2020	Z-0395-2021	—	terminated	Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions.
Sep 24, 2020	Z-0355-2021	—	terminated	Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions.
Sep 24, 2020	Z-0379-2021	—	terminated	Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions.
Sep 24, 2020	Z-0331-2021	—	terminated	Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions.
Sep 24, 2020	Z-0336-2021	—	terminated	Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions.
Sep 24, 2020	Z-0396-2021	—	terminated	Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions.
Sep 24, 2020	Z-0345-2021	—	terminated	Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions.
Sep 24, 2020	Z-0334-2021	—	terminated	Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions.
Sep 24, 2020	Z-0371-2021	—	terminated	Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions.
Sep 24, 2020	Z-0397-2021	—	terminated	Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions.
Aug 14, 2020	Z-0057-2021	—	terminated	The outer package is labeled as a Size C 38 mm, however, the implant inside the package is a Size E 42 mm.
May 5, 2020	Z-2217-2020	—	terminated	There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.
May 5, 2020	Z-2227-2020	—	terminated	There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.
May 5, 2020	Z-2214-2020	—	terminated	There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.
May 5, 2020	Z-2210-2020	—	terminated	There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.
May 5, 2020	Z-2220-2020	—	terminated	There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.
May 5, 2020	Z-2230-2020	—	terminated	There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.
May 5, 2020	Z-2223-2020	—	terminated	There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.
May 5, 2020	Z-2215-2020	—	terminated	There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.
May 5, 2020	Z-2233-2020	—	terminated	There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.
May 5, 2020	Z-2234-2020	—	terminated	There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.
May 5, 2020	Z-2226-2020	—	terminated	There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.
May 5, 2020	Z-2229-2020	—	terminated	There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.
May 5, 2020	Z-2212-2020	—	terminated	There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.
May 5, 2020	Z-2228-2020	—	terminated	There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.
May 5, 2020	Z-2231-2020	—	terminated	There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.
May 5, 2020	Z-2221-2020	—	terminated	There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.
May 5, 2020	Z-2218-2020	—	terminated	There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.
May 5, 2020	Z-2224-2020	—	terminated	There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.
May 5, 2020	Z-2225-2020	—	terminated	There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.
May 5, 2020	Z-2211-2020	—	terminated	There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.
May 5, 2020	Z-2219-2020	—	terminated	There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.
May 5, 2020	Z-2232-2020	—	terminated	There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.