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NexGen Option Stemmed Tibial Component Size 4, Item Number 00-5986-037-02

FDA Recall #Z-0467-2023 — Class II — December 6, 2022

Recall #Z-0467-2023 Date: December 6, 2022 Classification: Class II Status: Ongoing

Product Description

NexGen Option Stemmed Tibial Component Size 4, Item Number 00-5986-037-02

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.

Recalling Firm

Zimmer, Inc. — Warsaw, IN

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

2092

Distribution

Worldwide - US Nationwide distribution.

Code Information

All Unexpired Lots

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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