BEUDAMED
    FDA Enforcement Class II Ongoing

    OSS Modular Arthrodesis Nail, 7 Degree Collar Assembly with Locking Bolts-For use in the replacement of segmental defects of long bone, including midshaft replacement, and arthrodesis of the knee Item Number: CP260602

    Recall: Z-1036-2023 · Reported February 8, 2023

    Enforcement

    Recall Number
    Z-1036-2023
    Event ID
    91423
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Biomet, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    February 8, 2023
    Initiation Date
    November 29, 2022
    Classification Date
    January 27, 2023
    Address
    56 E Bell Dr, N/A, Warsaw, IN, 46582-6989, United States

    Description

    OSS Modular Arthrodesis Nail, 7 Degree Collar Assembly with Locking Bolts-For use in the replacement of segmental defects of long bone, including midshaft replacement, and arthrodesis of the knee Item Number: CP260602

    Reason

    Product missing the four small locking collar bolts resulting in extension of surgery to find a replacement

    Code Info

    UDI: (01)00880304082991(17)321103(10)136620 Lot Number: 136620

    Distribution

    US Nationwide distribution in the states of CA, KY, FL.

    Quantity

    2 units