The Recall Desk
HighFDA (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.

What this means for you

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

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.

Related recalls

Same category