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Biomet, Inc.

Last updated September 17, 2026

Information

Country: US
Address: 56 E Bell Dr, WARSAW, IN, 46581
Website: —
LinkedIn: —
Facebook: —
Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 1825034
DUNS Number: —

Catalogue (471)

Page 1 of 10

Device	Model / Reference	Registries	Class	Status
Taperloc® Complete Hip Stem	K251270	FDA 510(k)	Class II	Active
Right-Angle Nozzle	414900	FDA UDI	Class I	Active
Optivac Kit, 120 gram Triple Mix	418300	FDA UDI	Class I	Active
Cement Delivery System	110030623	FDA UDI	Class I	Active
Optivac Nozzle Slim	4154	FDA UDI	Class I	Active
T.e.s.s® Lid	A1700382	FDA UDI	Class I	Active
Biomet® Bone Cement R	110035371	FDA UDI	Class II	Active
Tess Top Insert Hemi	A1700386	FDA UDI	Class I	Active
Optivac Nozzle Revision	4155	FDA UDI	Class I	Active
Optivac Total Hip Kit	417000	FDA UDI	Class I	Active
Tess Base	A1700380	FDA UDI	Class I	Active
Cement Delivery System	4146	FDA UDI	Class I	Active
Refobacin® Bone Cement R	110034355	FDA UDI	Class II	Active
Optivac Fusion	419000	FDA UDI	Class I	Active
Knee Cementation Nozzle	4312	FDA UDI	Class I	Active
Refobacin® Bone Cement R	110034357	FDA UDI	Class II	Active
Optivac Kit, 120 gram Triple Mix	417300	FDA UDI	Class I	Active
Refobacin® Bone Cement R	110034358	FDA UDI	Class II	Active
Optivac Total Hip Kit	418000	FDA UDI	Class I	Active
Optivac Kit, 80 gram Double Mix	417200	FDA UDI	Class I	Active
Optivac Kit, 80 gram Double Mix	418200	FDA UDI	Class I	Active
Angled Nozzle	4149	FDA UDI	Class I	Active
Tess Bottom Insert Hemi	A1700384	FDA UDI	Class I	Active
Refobacin® Bone Cement R	110034356	FDA UDI	Class II	Active
Biomet® Bone Cement R	110035368	FDA UDI	Class II	Active
Optigun Ratchet	419500	FDA UDI	Class I	Active
Optigun II	419300	FDA UDI	Class I	Active
Optivac Kit, 40 gram single Mix	417100	FDA UDI	Class I	Active
Calcigen Psi Bone Graft Substitute	K030178	FDA 510(k)	Class II	Active
Zirconia Ceramic Modular Heads	K905687	FDA 510(k)	Class II	Active
StageOne Select Cement Spacer Molds for Temporary Hip Replacement	K161166	FDA 510(k)	Class II	Active
G7 Dual Mobility System	K150522	FDA 510(k)	Class II	Active
Modular Reach Hip	K994038	FDA 510(k)	Class II	Active
Lactosorb Rapidflap	K003281	FDA 510(k)	Class II	Active
Mallory/Head Smooth Femoral Component	K994007	FDA 510(k)	Class II	Active
Lorenz Surgical Threaded Dental Implant	K941619	FDA 510(k)	Class II	Active
Single Axle Total Elbow	K983036	FDA 510(k)	Class II	Active
Kennedy Tibial Component	K831513	FDA 510(k)	Class II	Active
Arcomxl Polyethylene Rx90 Acetabular Liners	K052255	FDA 510(k)	Class II	Active
Ringloc 36mm Line And Modular Femoral Heads	K032396	FDA 510(k)	Class II	Active
Taper 2 Porous Femoral Stem	K050441	FDA 510(k)	Class II	Active
Arcomxl Polyethylene Liners And Biolox Delta Heads	K051411	FDA 510(k)	Class II	Active
Porous Coated Acetabular Components	K050124	FDA 510(k)	Class III	Active
X-Series Integral Rpp Femoral Components	K042029	FDA 510(k)	Class II	Active
Arthrotek Cannula System	K934401	FDA 510(k)	Class II	Active
Relieved Reinforced Cup	K820539	FDA 510(k)	Class II	Active
Shp Hip System-Femoral Components/Acetabular Components/Modular Heads/Centralizers	K960984	FDA 510(k)	Class II	Active
Zirconia Ceramic Modular Head 9type Ii Taper	K915641	FDA 510(k)	Class II	Active
Modification To: Injectable Mimix	K012569	FDA 510(k)	Class II	Active
3i Calcium Sodium Phosphate Bone Cement	K003493	FDA 510(k)	Class II	Active

Related Companies

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Importers

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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.

Date	Recall No.	Class	Status	Reason
Sep 23, 2025	Z-0212-2026	—	open, classified	There is a potential for a missing slotted button assembly in one lot of ZipTight, Acute AC Joint Implant, Single Ziploop
Sep 9, 2025	Z-2619-2025	—	open, classified	The outer carton box label is for the JuggerKnot 1.0mm Mini products. However, the products within the carton are JuggerKnot 1.4mm Short devices.
Oct 21, 2024	Z-0477-2025	—	open, classified	Firm received complaints reporting that guides were warped when pulled out of packaging. This issue may result in extension of surgery to find another product, or may lead to adverse local tissue reaction leading to surgical intervention.
May 17, 2024	Z-2179-2024	—	open, classified	41 mm acetabular outer heads were potentially assembled with a 42 mm locking ring, may lead to joint instability leading requiring surgical intervention
Mar 13, 2024	Z-1607-2024	—	open, classified	Possible damage to the Vanguard Knee System AS Tibial Bearing caused during the manufacturing process.
Nov 2, 2023	Z-0570-2024	—	open, classified	One product complaint was received reporting that there was an incorrect adapter in the packaging. An adapter with neck length M/+0 was inside the product packaging, which should have contained an adapter with neck length S/-3.0. The difference in neck length may be recognized by the size (S or M) indicator on the device.
Nov 2, 2023	Z-0569-2024	—	open, classified	One product complaint was received reporting that there was an incorrect adapter in the packaging. An adapter with neck length M/+0 was inside the product packaging, which should have contained an adapter with neck length S/-3.0. The difference in neck length may be recognized by the size (S or M) indicator on the device.
Oct 9, 2023	Z-0382-2024	—	open, classified	Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery
Oct 9, 2023	Z-0386-2024	—	open, classified	Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery
Oct 9, 2023	Z-0381-2024	—	open, classified	Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery
Oct 9, 2023	Z-0374-2024	—	open, classified	Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery
Oct 9, 2023	Z-0370-2024	—	open, classified	Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery
Oct 9, 2023	Z-0380-2024	—	open, classified	Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery
Oct 9, 2023	Z-0377-2024	—	open, classified	Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery
Oct 9, 2023	Z-0373-2024	—	open, classified	Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery
Oct 9, 2023	Z-0371-2024	—	open, classified	Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery
Oct 9, 2023	Z-0388-2024	—	open, classified	Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery
Oct 9, 2023	Z-0378-2024	—	open, classified	Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery
Oct 9, 2023	Z-0375-2024	—	open, classified	Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery
Oct 9, 2023	Z-0387-2024	—	open, classified	Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery
Oct 9, 2023	Z-0385-2024	—	open, classified	Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery
Oct 9, 2023	Z-0376-2024	—	open, classified	Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery
Oct 9, 2023	Z-0372-2024	—	open, classified	Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery
Oct 9, 2023	Z-0379-2024	—	open, classified	Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery
Oct 9, 2023	Z-0383-2024	—	open, classified	Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery
Oct 9, 2023	Z-0384-2024	—	open, classified	Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery
Feb 6, 2023	Z-1284-2023	—	open, classified	The outer package labeling and product etch are a 40 mm Size D liner, however, the implant is a 38 mm Size C liner.
Dec 29, 2022	Z-1043-2023	—	open, classified	Components Incorrectly labeled as either smaller or larger and incorrect side (right/left).
Dec 29, 2022	Z-1042-2023	—	open, classified	Components Incorrectly labeled as either smaller or larger and incorrect side (right/left).
Dec 15, 2022	Z-1018-2023	—	open, classified	Packaged in the incorrect shelf carton. Incorrect shelf carton; outer carton is smaller than the required outer carton, which forces the Tyvex pouch to be folded and packaged in the carton causing compound creases and compromise the sterile barrier
Nov 29, 2022	Z-1036-2023	—	open, classified	Product missing the four small locking collar bolts resulting in extension of surgery to find a replacement
Feb 14, 2022	Z-0811-2022	—	terminated	Packaging of various implants may not have sufficient adhesion on all sides, leading to loss of sterile barrier integrity. Use of product poses risk of infection, leading to surgical intervention, and/or extension of surgery to find another part.
Feb 14, 2022	Z-0812-2022	—	terminated	Packaging of various implants may not have sufficient adhesion on all sides, leading to loss of sterile barrier integrity. Use of product poses risk of infection, leading to surgical intervention, and/or extension of surgery to find another part.
Feb 14, 2022	Z-0810-2022	—	terminated	Packaging of various implants may not have sufficient adhesion on all sides, leading to loss of sterile barrier integrity. Use of product poses risk of infection, leading to surgical intervention, and/or extension of surgery to find another part.
Feb 14, 2022	Z-0809-2022	—	terminated	Packaging of various implants may not have sufficient adhesion on all sides, leading to loss of sterile barrier integrity. Use of product poses risk of infection, leading to surgical intervention, and/or extension of surgery to find another part.
Jan 7, 2022	Z-0677-2022	—	terminated	The products in scope underwent an incorrect rework operation for the porous plasma sprayed coating. Internal testing indicated that the parts may not have sufficient adhesion strength. The scope was identified to be all lots that were porous plasma coated or recoated at a vendor that were then reworked through the internal waterjet rework process. The waterjet rework process for porous plasma coating is not validated for products that were coated at a vendor.
Jan 7, 2022	Z-0673-2022	—	terminated	The products in scope underwent an incorrect rework operation for the porous plasma sprayed coating. Internal testing indicated that the parts may not have sufficient adhesion strength. The scope was identified to be all lots that were porous plasma coated or recoated at a vendor that were then reworked through the internal waterjet rework process. The waterjet rework process for porous plasma coating is not validated for products that were coated at a vendor.
Jan 7, 2022	Z-0670-2022	—	terminated	The products in scope underwent an incorrect rework operation for the porous plasma sprayed coating. Internal testing indicated that the parts may not have sufficient adhesion strength. The scope was identified to be all lots that were porous plasma coated or recoated at a vendor that were then reworked through the internal waterjet rework process. The waterjet rework process for porous plasma coating is not validated for products that were coated at a vendor.
Jan 7, 2022	Z-0674-2022	—	terminated	The products in scope underwent an incorrect rework operation for the porous plasma sprayed coating. Internal testing indicated that the parts may not have sufficient adhesion strength. The scope was identified to be all lots that were porous plasma coated or recoated at a vendor that were then reworked through the internal waterjet rework process. The waterjet rework process for porous plasma coating is not validated for products that were coated at a vendor.
Jan 7, 2022	Z-0675-2022	—	terminated	The products in scope underwent an incorrect rework operation for the porous plasma sprayed coating. Internal testing indicated that the parts may not have sufficient adhesion strength. The scope was identified to be all lots that were porous plasma coated or recoated at a vendor that were then reworked through the internal waterjet rework process. The waterjet rework process for porous plasma coating is not validated for products that were coated at a vendor.
Jan 7, 2022	Z-0672-2022	—	terminated	The products in scope underwent an incorrect rework operation for the porous plasma sprayed coating. Internal testing indicated that the parts may not have sufficient adhesion strength. The scope was identified to be all lots that were porous plasma coated or recoated at a vendor that were then reworked through the internal waterjet rework process. The waterjet rework process for porous plasma coating is not validated for products that were coated at a vendor.
Jan 7, 2022	Z-0671-2022	—	terminated	The products in scope underwent an incorrect rework operation for the porous plasma sprayed coating. Internal testing indicated that the parts may not have sufficient adhesion strength. The scope was identified to be all lots that were porous plasma coated or recoated at a vendor that were then reworked through the internal waterjet rework process. The waterjet rework process for porous plasma coating is not validated for products that were coated at a vendor.
Jan 7, 2022	Z-0676-2022	—	terminated	The products in scope underwent an incorrect rework operation for the porous plasma sprayed coating. Internal testing indicated that the parts may not have sufficient adhesion strength. The scope was identified to be all lots that were porous plasma coated or recoated at a vendor that were then reworked through the internal waterjet rework process. The waterjet rework process for porous plasma coating is not validated for products that were coated at a vendor.
Jun 2, 2021	Z-2270-2021	—	terminated	Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention
Jun 2, 2021	Z-2268-2021	—	terminated	Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention
Jun 2, 2021	Z-2266-2021	—	terminated	Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention
Jun 2, 2021	Z-2274-2021	—	terminated	Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention
Jun 2, 2021	Z-2265-2021	—	terminated	Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention
Jun 2, 2021	Z-2260-2021	—	terminated	Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention
Jun 2, 2021	Z-2267-2021	—	terminated	Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention
Jun 2, 2021	Z-2271-2021	—	terminated	Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention
Jun 2, 2021	Z-2261-2021	—	terminated	Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention
Jun 2, 2021	Z-2259-2021	—	terminated	Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention
Jun 2, 2021	Z-2264-2021	—	terminated	Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention
Jun 2, 2021	Z-2273-2021	—	terminated	Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention
Jun 2, 2021	Z-2262-2021	—	terminated	Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention
Jun 2, 2021	Z-2275-2021	—	terminated	Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention
Jun 2, 2021	Z-2269-2021	—	terminated	Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention
Jun 2, 2021	Z-2272-2021	—	terminated	Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention
Jun 2, 2021	Z-2263-2021	—	terminated	Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention
Jan 15, 2021	Z-1131-2021	—	terminated	Zimmer Biomet is conducting a lot specific medical device recall for the Comprehensive Reverse Shoulder Central Screw, 25 MM Length. It has been determined through a complaint investigation that a 40 MM length central screw was packaged and labeled as a 25 MM length central screw.
Dec 23, 2020	Z-0882-2021	—	terminated	The instruments may become cold welded together when the drill is inserted through the Soft Tissue Guide. This prevents disassociation of the instruments and potentially leads to an increased chance of fracture of the drill.
Dec 1, 2020	Z-0723-2021	—	terminated	Incorrect bolt -tibial bolts in package instead of femoral bolts may delay procedure
Nov 25, 2020	Z-0616-2021	—	terminated	Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.
Nov 25, 2020	Z-0619-2021	—	terminated	Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.
Nov 25, 2020	Z-0620-2021	—	terminated	Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.
Nov 25, 2020	Z-0617-2021	—	terminated	Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.
Nov 25, 2020	Z-0631-2021	—	terminated	Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.
Nov 25, 2020	Z-0621-2021	—	terminated	Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.
Nov 25, 2020	Z-0627-2021	—	terminated	Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.
Nov 25, 2020	Z-0624-2021	—	terminated	Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.
Nov 25, 2020	Z-0630-2021	—	terminated	Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.
Nov 25, 2020	Z-0626-2021	—	terminated	Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.
Nov 25, 2020	Z-0625-2021	—	terminated	Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.
Nov 25, 2020	Z-0623-2021	—	terminated	Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.
Nov 25, 2020	Z-0629-2021	—	terminated	Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.
Nov 25, 2020	Z-0618-2021	—	terminated	Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.
Nov 25, 2020	Z-0628-2021	—	terminated	Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.
Nov 25, 2020	Z-0622-2021	—	terminated	Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.
Sep 4, 2020	Z-0081-2021	—	terminated	Product not properly being aligned with the adequate gamma sterilization group and result in the product not being properly sterilized
Sep 4, 2020	Z-0083-2021	—	terminated	Product not properly being aligned with the adequate gamma sterilization group and result in the product not being properly sterilized
Sep 4, 2020	Z-0082-2021	—	terminated	Product not properly being aligned with the adequate gamma sterilization group and result in the product not being properly sterilized
Sep 4, 2020	Z-0084-2021	—	terminated	Product not properly being aligned with the adequate gamma sterilization group and result in the product not being properly sterilized
Sep 3, 2020	Z-0097-2021	—	terminated	Zimmer Biomet is conducting a medical device recall for three lots of the RingLoc Bi-Polar Hip system Acetabular Cup. The affected lots were gamma sterilized twice. Sufficient data does not exist to support the functionality, shelf life, or package integrity for more than one-time sterilization.
Sep 2, 2020	Z-0093-2021	—	terminated	Product potentially being packaged without a taper adapter or baseplate. The package should contain one (1) baseplate and one (1) taper adapter, product may be packaged with two (2) baseplates and no (0) adapters or with no (0) baseplates and two (2) adapters
May 14, 2020	Z-2311-2020	—	terminated	Distributed to the field without having completed design history files or design transfer activities
May 14, 2020	Z-2313-2020	—	terminated	Distributed to the field without having completed design history files or design transfer activities
May 14, 2020	Z-2312-2020	—	terminated	Distributed to the field without having completed design history files or design transfer activities
May 14, 2020	Z-2316-2020	—	terminated	Distributed to the field without having completed design history files or design transfer activities
May 14, 2020	Z-2315-2020	—	terminated	Distributed to the field without having completed design history files or design transfer activities
May 14, 2020	Z-2322-2020	—	terminated	Distributed to the field without having completed design history files or design transfer activities
May 14, 2020	Z-2310-2020	—	terminated	Distributed to the field without having completed design history files or design transfer activities
May 14, 2020	Z-2323-2020	—	terminated	Distributed to the field without having completed design history files or design transfer activities
May 14, 2020	Z-2317-2020	—	terminated	Distributed to the field without having completed design history files or design transfer activities
May 14, 2020	Z-2321-2020	—	terminated	Distributed to the field without having completed design history files or design transfer activities
May 14, 2020	Z-2319-2020	—	terminated	Distributed to the field without having completed design history files or design transfer activities
May 14, 2020	Z-2324-2020	—	terminated	Distributed to the field without having completed design history files or design transfer activities
May 14, 2020	Z-2308-2020	—	terminated	Distributed to the field without having completed design history files or design transfer activities
May 14, 2020	Z-2304-2020	—	terminated	Distributed to the field without having completed design history files or design transfer activities
May 14, 2020	Z-2320-2020	—	terminated	Distributed to the field without having completed design history files or design transfer activities