The Recall Desk
ModerateFDA (Devices)·Z-0467-2023·Announced 2022-12-21

NexGen Option Stemmed Tibial Knee Component Recalled for Higher Revision Rates

Zimmer Biomet is recalling NexGen Option Stemmed Tibial knee components (2,092 units) due to clinically significant higher revision rates when used with specific femoral components. The voluntary recall prevents future implantation with these problematic combinations.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is a voluntary Class II recall with no reported adverse events or injuries. The recall is precautionary, initiated by the manufacturer based on registry data showing higher revision rates when specific device combinations are used, without quantified patient harm or acute safety failures.

Plain-English summary

Zimmer Biomet is voluntarily recalling the NexGen Option Stemmed Tibial Component Size 4 (Item Number 00-5986-037-02), a knee replacement component. The recall affects 2,092 units with worldwide distribution.

The recall is based on data from the United Kingdom National Joint Registry showing that these tibial components have clinically and statistically significant higher overall revision rates when used with either the Legacy Posterior Stabilized (LPS) Flex or LPS Flex Gender Solutions Femoral components, compared to other total knee replacement approaches.

Zimmer Biomet is removing the product from inventory to prevent future implantation with these specific femoral combinations. This action is designed to mitigate the increased risk of patients needing revision surgery. Patients who have received this device should consult their healthcare provider for advice on whether additional monitoring or follow-up is needed.

The recalled product

Product
NexGen Option Stemmed Tibial Component Size 4, Item Number 00-5986-037-02
Manufacturer
Zimmer, Inc.
Category
Medical Device — Orthopedic Joint Replacement
Hazard
  • revision-risk

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