# FDA recall Z-0471-2023

> **Zimmer, Inc.** · Class II · device recall initiated 2022-12-06.

## Product

NexGen Option Stemmed Tibial Component Size 8, Item Number 00-5986-057-02

## 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.

## Distribution

Worldwide - US Nationwide distribution.

## Key facts

- **Recall number:** Z-0471-2023
- **Recalling firm:** Zimmer, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-12-06
- **Report date:** 2022-12-21

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Warsaw, IN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0471-2023

## Citation

> AI Analytics. FDA recall Z-0471-2023. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-0471-2023. Source: US FDA. Licensed CC0.

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