Agency classClass IIOur severity:High FDA (Devices)·Z-0469-2023·Announced 2022-12-21

Zimmer NexGen Option Stemmed Tibial Component Voluntary Recall Due to Higher Revision Rates

Zimmer is recalling NexGen Option Stemmed Tibial Components due to clinically significant higher revision rates when used with specific femoral components. Patients should contact their surgeon to discuss their implant.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This Class II recall involves a risk-of-harm medical device with clinically and statistically significant higher revision rates when used with specific femoral components. Although no illnesses or injuries have been reported, the registry data substantiates the device hazard, meeting the criterion for High severity.

Plain-English summary

Zimmer, Inc. is recalling NexGen Option Stemmed Tibial Components (Size 6, Item Number 00-5986-047-02), a prosthetic component used in total knee replacement surgery. The recall affects all unexpired lots, with worldwide and United States distribution.

The recall is based on data from the United Kingdom National Joint Registry, which identified clinically and statistically significant higher revision rates when these tibial components are implanted together with either the Legacy Posterior Stabilized (LPS) Flex or LPS Flex Gender Solutions Femoral (GSF) components, compared to other total knee replacement designs.

Patients who have received these tibial components should contact their surgeon to determine whether their implant includes one of the affected femoral components. Those with the affected combination should work with their surgeon to discuss appropriate follow-up or other actions. Zimmer is removing these components from inventory to prevent future use in these specific combinations.

The recalled product

Product: NexGen Option Stemmed Tibial Component Size 6, Item Number 00-5986-047-02
Manufacturer: Zimmer, Inc.
Category: Medical Device — Orthopedic Implant / Knee Replacement
Hazard: implant-revision
component-mismatch
Affected units: 1,366

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

All Unexpired Lots

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 6 recalled by Zimmer, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 6 products in this recall →

Same manufacturer · Zimmer, Inc.

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Same hazard · implant revision