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Zimmer Orthopaedic Surgical Products

Last updated May 23, 2026

What Zimmer Orthopaedic Surgical Products makes

Zimmer Orthopaedic Surgical Products manufactures surgical saw blades (oscillating and reciprocating, single-use), surgical pneumatic tourniquet systems, surgical helmet systems, sequential venous compression system inflators, dermatome handpieces, leg procedure positioners, and surgical fluid/smoke waste management system suction units.

The company's portfolio includes Class I and Class II devices, which are listed in the FDA Unique Device Identifier (UDI) registry. Zimmer Orthopaedic Surgical Products is based in the US.

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

Frequently asked questions

What does Zimmer Orthopaedic Surgical Products manufacture?

Where is Zimmer Orthopaedic Surgical Products based?

Zimmer Orthopaedic Surgical Products is based in the United States, as indicated by the country information provided in the device data.

Which regulatory registries list Zimmer Orthopaedic Surgical Products' devices?

Zimmer Orthopaedic Surgical Products' devices are listed in the FDA Unique Device Identifier (UDI) registry, as specified in the device data provided.

How are Zimmer Orthopaedic Surgical Products' devices classified?

Zimmer Orthopaedic Surgical Products manufactures Class I and Class II devices, which are lower-risk medical devices compared to Class III devices, as indicated in the device data.

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 (1346)

Page 3 of 27

Device	Model / Reference	Registries	Class	Status
Stablecut®	13105137LF1	FDA UDI	Class I	Active
Stablecut®	35064089YX1	FDA UDI	Class I	Active
Stablecut®	11-2330	FDA UDI	Class I	Active
Stablecut®	20105137AVC	FDA UDI	Class I	Active
Stablecut®	13105127YF1	FDA UDI	Class I	Active
Stablecut®	25090127AF1	FDA UDI	Class I	Active
Totalshield®	00-9900-104-00	FDA UDI	Class II	Active
OmniSight™	OMST1065	FDA UDI	Class I	Active
Stablecut®	13090137AF1	FDA UDI	Class I	Active
Stablecut®	20090119XCW	FDA UDI	Class I	Active
Stablecut®	19110119YG1	FDA UDI	Class I	Active
Stablecut®	48061100YLJ	FDA UDI	Class I	Active
Stablecut®	20100119XC1	FDA UDI	Class I	Active
Stablecut®	506139	FDA UDI	Class I	Active
Stablecut®	25090137AG1	FDA UDI	Class I	Active
Stablecut®	25105127YGC	FDA UDI	Class I	Active
Stablecut®	506111	FDA UDI	Class I	Active
Stablecut®	25090137LGC	FDA UDI	Class I	Active
Stablecut®	20100127YVC	FDA UDI	Class I	Active
Stablecut®	506089	FDA UDI	Class I	Active
Stablecut®	13090127AG1	FDA UDI	Class I	Active
Stablecut®	11-2618	FDA UDI	Class I	Active
Stablecut®	11-3541	FDA UDI	Class I	Active
Stablecut®	20080137AGC	FDA UDI	Class I	Active
Hemovac® Wound Drainage System	00-1500-021-10	FDA UDI	Class I	Unknown
Stablecut®	25090119LB1	FDA UDI	Class I	Active
Stablecut®	223000263	FDA UDI	Class I	Active
Stablecut®	13076119NR1	FDA UDI	Class I	Active
Stablecut®	21090119AV1	FDA UDI	Class I	Active
Stablecut®	25090147LV1	FDA UDI	Class I	Active
Stablecut®	11-3080	FDA UDI	Class I	Active
Stablecut®	506122	FDA UDI	Class I	Active
Stablecut®	07018038AMC	FDA UDI	Class I	Active
Stablecut®	506121	FDA UDI	Class I	Active
Stablecut®	11-2873	FDA UDI	Class I	Active
Stablecut®	25090137YGC	FDA UDI	Class I	Active
Stablecut®	25090147AV1	FDA UDI	Class I	Active
Stablecut®	19105127AF1	FDA UDI	Class I	Active
Stablecut®	19070089XF1	FDA UDI	Class I	Active
Stablecut®	10070119NR1	FDA UDI	Class I	Active
Stablecut®	506140	FDA UDI	Class I	Active
Stablecut®	13065127XF1	FDA UDI	Class I	Active
Stablecut®	506111	FDA UDI	Class I	Active
Totalshield®	89-9901-000-00	FDA UDI	Class II	Active
Stablecut®	25090147AB1	FDA UDI	Class I	Active
Stablecut®	506105	FDA UDI	Class I	Active
Stablecut®	506126	FDA UDI	Class I	Active
Stablecut®	20038127YA1	FDA UDI	Class I	Active
Stablecut®	21090127AV1	FDA UDI	Class I	Active
Stablecut®	11-2325	FDA UDI	Class I	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (15)

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

Zimmer Orthopaedic Surgical Products has 15 recall records, with the earliest initiated on 2004-10-27 and the most recent on 2007-12-18. All recalls have been terminated. The reasons given include port/tube bond separation in cuffs during surgery and compromised sterility due to silicone stain effects on Tyvek lids.

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
Dec 18, 2007	Z-0864-2008	—	terminated	Sterility (package integrity) compromised; The effect of a silicone stain produced during assembly operations on the sterility barrier properties of the Tyvek lids has not been validated by the firm.
Dec 18, 2007	Z-0863-2008	—	terminated	Sterility (package integrity) compromised; The effect of a silicone stain produced during assembly operations on the sterility barrier properties of the Tyvek lids has not been validated by the firm.
Dec 18, 2007	Z-0860-2008	—	terminated	Sterility (package integrity) compromised; The effect of a silicone stain produced during assembly operations on the sterility barrier properties of the Tyvek lids has not been validated by the firm.
Dec 18, 2007	Z-0865-2008	—	terminated	Sterility (package integrity) compromised; The effect of a silicone stain produced during assembly operations on the sterility barrier properties of the Tyvek lids has not been validated by the firm.
Dec 18, 2007	Z-0857-2008	—	terminated	Sterility (package integrity) compromised; The effect of a silicone stain produced during assembly operations on the sterility barrier properties of the Tyvek lids has not been validated by the firm.
Dec 18, 2007	Z-0861-2008	—	terminated	Sterility (package integrity) compromised; The effect of a silicone stain produced during assembly operations on the sterility barrier properties of the Tyvek lids has not been validated by the firm.
Dec 18, 2007	Z-0862-2008	—	terminated	Sterility (package integrity) compromised; The effect of a silicone stain produced during assembly operations on the sterility barrier properties of the Tyvek lids has not been validated by the firm.
Dec 18, 2007	Z-0859-2008	—	terminated	Sterility (package integrity) compromised; The effect of a silicone stain produced during assembly operations on the sterility barrier properties of the Tyvek lids has not been validated by the firm.
Dec 18, 2007	Z-0856-2008	—	terminated	Sterility (package integrity) compromised; The effect of a silicone stain produced during assembly operations on the sterility barrier properties of the Tyvek lids has not been validated by the firm.
Dec 18, 2007	Z-0858-2008	—	terminated	Sterility (package integrity) compromised; The effect of a silicone stain produced during assembly operations on the sterility barrier properties of the Tyvek lids has not been validated by the firm.
Feb 11, 2005	Z-0565-05	—	terminated	The port/tube bond in the affected cuffs may separate during surgery causing the pressure in the cuff to release.
Feb 11, 2005	Z-0564-05	—	terminated	The port/tube bond in the affected cuffs may separate during surgery causing the pressure in the cuff to release.
Oct 27, 2004	Z-0388-05	—	terminated	The port/tube bond in the affected cuffs may separate during surgery causing the pressure in the cuff to release.
Oct 27, 2004	Z-0390-05	—	terminated	The port/tube bond in the affected cuffs may separate during surgery causing the pressure in the cuff to release.
Oct 27, 2004	Z-0389-05	—	terminated	The port/tube bond in the affected cuffs may separate during surgery causing the pressure in the cuff to release.