Zimmer, Inc.: Medical Device Recall in 2022 - (Recall #: Z-0469-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

NexGen Option Stemmed Tibial Component Size 6, Item Number 00-5986-047-02

Product Classification:

Class II

Date Initiated: December 6, 2022

Date Posted: December 21, 2022

Recall Number: Z-0469-2023

Event ID: 91073

Reason for Recall:

Zimmer Biomet is conducting a voluntary medical device recall related to the NexGen Stemmed Option Tibial Components due to the clinically and statistically significant higher overall revision rates when these tibial components are used with either the Legacy Posterior Stabilized (LPS) Flex or LPS Flex Gender Solutions Femoral (GSF) components as compared to other total knee arthroplasties in the United Kingdom National Joint Registry (UK NJR). Removing the NexGen Stemmed Option Tibial Component f rom inventory will prevent its future implantation with either the LPS Flex or LPS Flex GSF femoral components and mitigate the increased revision risk with these two specific combinations of tibial and femoral component.

Status: Ongoing

Product Quantity: 1366

Code Information:

All Unexpired Lots

Distribution Pattern:

Worldwide - US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated