The Recall Desk
HighFDA (Devices)·Z-0470-2023·Announced 2022-12-21

Zimmer NexGen Stemmed Tibial Components recalled for higher revision rates

Zimmer is voluntarily recalling NexGen Option Stemmed Tibial Component Size 7 (1,049 units) due to higher-than-expected revision rates when used with specific femoral components, based on UK registry data.

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: FDA Class II recall involving a risk-of-harm product (orthopedic implant with documented higher revision rates from UK registry data). No reported deaths, hospitalizations, or acute injuries; the hazard is increased need for revision surgery.

Plain-English summary

Zimmer Biomet is voluntarily recalling the NexGen Option Stemmed Tibial Component Size 7 (Item Number 00-5986-057-01) due to clinically and statistically significant higher revision rates when used with specific femoral components. According to the United Kingdom National Joint Registry, patients who received these tibial components paired with either the Legacy Posterior Stabilized Flex (LPS Flex) or LPS Flex Gender Solutions Femoral (GSF) components required revision surgery more often than patients receiving other total knee arthroplasties.

Approximately 1,049 units were distributed worldwide, including throughout the United States. All unexpired lots of Item Number 00-5986-057-01 are affected by the recall.

Zimmer is removing the NexGen Stemmed Option Tibial Component from inventory to prevent future implantation with the LPS Flex or LPS Flex GSF femoral components. Patients who received this implant should consult with their surgeon if they have concerns about their knee replacement. Healthcare providers should contact Zimmer for guidance on managing affected implants.

The recalled product

Product
NexGen Option Stemmed Tibial Component Size 7, Item Number 00-5986-057-01
Manufacturer
Zimmer, Inc.
Category
Medical Device — Orthopedic Implant
Hazard
  • implant-revision
  • device-performance

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