BEUDAMED
    FDA Enforcement Class II Ongoing

    Oxford Partial Knee System, Fixed Lateral Tibial Construct- Intended to replace part of a knee joint when used in conjunction with a femoral and tibial component Item Number: 154341

    Recall: Z-1018-2023 · Reported February 1, 2023

    Enforcement

    Recall Number
    Z-1018-2023
    Event ID
    91365
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Biomet, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 1, 2023
    Initiation Date
    December 15, 2022
    Classification Date
    January 26, 2023
    Address
    56 E Bell Dr, N/A, Warsaw, IN, 46582-6989, United States

    Description

    Oxford Partial Knee System, Fixed Lateral Tibial Construct- Intended to replace part of a knee joint when used in conjunction with a femoral and tibial component Item Number: 154341

    Reason

    Packaged in the incorrect shelf carton. Incorrect shelf carton; outer carton is smaller than the required outer carton, which forces the Tyvex pouch to be folded and packaged in the carton causing compound creases and compromise the sterile barrier

    Code Info

    UDI: (01) 05019279515349 (17) 241123 (10) 077830 Lot Number: 077830

    Distribution

    Worldwide distribution - US Nationwide distribution in the states of IN, KY and the countries of Canada, New Zealand, Japan, Netherlands.

    Quantity

    7 units