Recall Z-0466-2023— Zimmer, Inc.

Name: FDA recall Z-0466-2023
Creator: U.S. Food and Drug Administration
Published: 2022-12-06

Class II · Ongoing

Class II FDA medical device recall by Zimmer, Inc., initiated 2022-12-06. It names one FDA 510(k) clearance: K872379. Product: NexGen Option Stemmed Tibial Component Size 3, Item Number 00-5986-037-01. Reason: 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.
Classification: Class II
Status: Ongoing
Initiated: 2022-12-06
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K872379 — INSALL/BURSTEIN* II MODULAR TOTAL KNEEZimmer, Inc.·cleared 1987-10-28

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

NexGen Option Stemmed Tibial Component Size 3, Item Number 00-5986-037-01

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.