BEUDAMED
    FDA Enforcement Class II Completed

    ENDURO SPECIAL KEY TIB.LOCK.RING F1/10MM product code NP462R used with EnduRo Total Knee System. instrument used during orthopedic implant surgery.

    Recall: Z-1391-2022 · Reported July 27, 2022

    Enforcement

    Recall Number
    Z-1391-2022
    Event ID
    90484
    Classification
    Class II
    Status
    Completed
    Product Type
    Devices
    Firm
    Aesculap Implant Systems LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 27, 2022
    Initiation Date
    November 12, 2019
    Classification Date
    July 15, 2022
    Address
    3773 Corporate Pkwy, N/A, Center Valley, PA, 18034-8217, United States

    Description

    ENDURO SPECIAL KEY TIB.LOCK.RING F1/10MM product code NP462R used with EnduRo Total Knee System. instrument used during orthopedic implant surgery.

    Reason

    Nonfunctional key due to the potential for damage to the key pins cause by force of use during assembly of the tibia locking ring.

    Code Info

    UDI-DI (GTIN): 04046963419639

    Distribution

    US Nationwide distribution in the states of AL, AZ, CA, CO, ID, IL, LA, MA, MO, NC, OK, TX, WI.

    Quantity

    67