The Recall Desk
HighFDA (Devices)·Z-0466-2023·Announced 2022-12-21

NexGen Stemmed Tibial Component Recalled Due to Higher Revision Rates

Zimmer is recalling NexGen Option Stemmed Tibial Components due to higher revision rates when used with certain femoral components in knee replacements.

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 medical device recall for increased revision risk in knee implants. No hospitalizations, injuries, or deaths are reported. This is a risk-of-harm product where injury has not yet been reported, meeting the rubric criteria for Score 3.

Plain-English summary

The NexGen Option Stemmed Tibial Component Size 3, manufactured by Zimmer, Inc., is being recalled. This component is used as part of total knee replacement surgery. Approximately 1,673 units have been distributed worldwide, including throughout the United States. All unexpired lots are included in the recall.

Zimmer is conducting this voluntary recall because data from the United Kingdom National Joint Registry showed clinically and statistically significant higher overall revision rates when this tibial component is paired with either the LPS Flex or LPS Flex Gender Solutions Femoral components, compared to other knee replacement combinations. Revision surgery may be necessary when implants fail to perform as expected. Zimmer is removing affected inventory to prevent future implantations with these specific femoral combinations.

Patients or healthcare providers who have questions should contact Zimmer, Inc. directly. Surgeons should not use remaining NexGen Option Stemmed Tibial Component Size 3 units with the identified femoral components.

The recalled product

Product
NexGen Option Stemmed Tibial Component Size 3, Item Number 00-5986-037-01
Manufacturer
Zimmer, Inc.
Category
Medical Device — Knee Implant / Orthopedic
Hazard
  • revision-risk
  • device-incompatibility

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