The Recall Desk
HighFDA (Devices)·Z-0468-2023·Announced 2022-12-21

Zimmer Recalls NexGen Stemmed Tibial Components Due to Higher Revision Rates

Zimmer Inc. is recalling NexGen Option Stemmed Tibial Components due to clinically and statistically significant higher revision rates when used with specific femoral components. The components are being removed from inventory.

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 is an FDA Class II recall of a prosthetic joint component with documented, statistically significant higher revision rates when used with specific femoral components, indicating increased device failure. No specific patient injuries or hospitalizations have been reported in the source material.

Plain-English summary

Zimmer, Inc. is conducting a voluntary recall of the NexGen Option Stemmed Tibial Component Size 5 (Item Number 00-5986-047-01). Approximately 2,460 units have been distributed nationwide and worldwide to hospitals and medical facilities. The recall applies to all unexpired lots.

The recall is due to clinically and statistically significant higher overall revision rates observed in the United Kingdom National Joint Registry (UK NJR) when these tibial components are used in combination with either the Legacy Posterior Stabilized (LPS) Flex Femoral components or the LPS Flex Gender Solutions Femoral (GSF) components. These revision rates are higher compared to other total knee arthroplasty combinations.

Healthcare providers and facilities are instructed to remove this component from inventory immediately to prevent any future implantation with the LPS Flex or LPS Flex GSF femoral components. Zimmer is taking this action to mitigate the increased revision risk associated with these specific component combinations.

The recalled product

Product
NexGen Option Stemmed Tibial Component Size 5, Item Number 00-5986-047-01
Manufacturer
Zimmer, Inc.
Category
Medical Device — Knee Replacement Component
Hazard
  • implant-failure

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