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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
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PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: —

Catalogue (1346)

Page 27 of 27

Device	Model / Reference	Registries	Class	Status
Alvarado® Knee Support	00-1320-015-10	FDA UDI	Class I	Active
Stablecut®	12076100SRT	FDA UDI	Class I	Active
Stablecut®	06034060SMY	FDA UDI	Class I	Active
Stablecut®	13070147YL1	FDA UDI	Class I	Active
Stablecut®	25090127AV1	FDA UDI	Class I	Active
Stablecut®	13090137XG1	FDA UDI	Class I	Active
Hemovac® Wound Drainage System	00-1500-023-10	FDA UDI	Class I	Unknown
Stablecut®	19105127LG1	FDA UDI	Class I	Active
Hemovac® Wound Drainage System	00-1500-014-10	FDA UDI	Class I	Unknown
Stablecut®	13076089UR1	FDA UDI	Class I	Active
Stablecut®	19105119YG1	FDA UDI	Class I	Active
Stablecut®	506123	FDA UDI	Class I	Active
Stablecut®	25090127CG1	FDA UDI	Class I	Active
Stablecut®	19105119AG1	FDA UDI	Class I	Active
A.T.S.® Personalized Pressure®	60-4000-301-01	FDA UDI	Class I	Active
Stablecut®	11-4130	FDA UDI	Class I	Active
Stablecut®	05025060LMY	FDA UDI	Class I	Active
Stablecut®	06046119UR1	FDA UDI	Class I	Active
Stablecut®	19090127LG1	FDA UDI	Class I	Active
Stablecut®	506079	FDA UDI	Class I	Active
Stablecut®	21090119AV1	FDA UDI	Class I	Active
Stablecut®	09025060LMY	FDA UDI	Class I	Active
Totalshield®	00-9900-200-02	FDA UDI	Class II	Active
Stablecut®	09025060AMF	FDA UDI	Class I	Active
ActiveCare	ActiveCare Thigh sleeve medium	FDA UDI	Class II	Active
Stablecut®	25090119XF1	FDA UDI	Class I	Active
IntelliCart™	UE514010400	FDA UDI	Class II	Active
Stablecut®	25070100XF1	FDA UDI	Class I	Active
Stablecut®	19110119AG1	FDA UDI	Class I	Active
Stablecut®	11-2608	FDA UDI	Class I	Active
Stablecut®	19095137XF1	FDA UDI	Class I	Active
Stablecut®	13105137AF1	FDA UDI	Class I	Active
Stablecut®	13076089LR1	FDA UDI	Class I	Active
Stablecut®	30065119LTL	FDA UDI	Class I	Active
Stablecut®	20100137LVC	FDA UDI	Class I	Active
Stablecut®	20100137AVC	FDA UDI	Class I	Active
Stablecut®	19100127AF1	FDA UDI	Class I	Active
Stablecut®	25090089AL1	FDA UDI	Class I	Active
Stablecut®	19105137YF1	FDA UDI	Class I	Active
Stablecut®	506092	FDA UDI	Class I	Active
Stablecut®	14041060AMX	FDA UDI	Class I	Active
Stablecut®	13090137LF1	FDA UDI	Class I	Active
Stablecut®	11-3766	FDA UDI	Class I	Active
Stablecut®	21100119XG1	FDA UDI	Class I	Active
TotalShield® II Zippered Surgical Toga, 2XL	00992041310	FDA UDI	Class II	Active
Zimmer Ambulatory Pump Pain Management System	K050433	FDA 510(k)	Class II	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 (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.