BEUDAMED
    FDA Enforcement Class II Ongoing

    NexGen Option Stemmed Tibial Component Size 5, Item Number 00-5986-047-01

    Recall: Z-0468-2023 · Reported December 21, 2022

    Enforcement

    Recall Number
    Z-0468-2023
    Event ID
    91073
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Zimmer, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 21, 2022
    Initiation Date
    December 6, 2022
    Classification Date
    December 9, 2022
    Address
    1800 W Center St, N/A, Warsaw, IN, 46580-2304, United States

    Description

    NexGen Option Stemmed Tibial Component Size 5, Item Number 00-5986-047-01

    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.

    Code Info

    All Unexpired Lots

    Distribution

    Worldwide - US Nationwide distribution.

    Quantity

    2460