BEUDAMED
    FDA Recall 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 · Initiated November 12, 2019

    Recall

    Recall Number
    Z-1391-2022
    Event Number
    90484
    Firm
    Aesculap Implant Systems LLC
    FEI Number
    2916714
    Product Code
    LXH
    Status
    Completed
    Root Cause
    Device Design
    Initiated
    November 12, 2019
    Address
    3773 Corporate Pkwy, Center Valley, PA, 18034-8217

    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.

    Action

    A notification letter was issued November 12, 2019 mailed USPS certified with registered return receipt. The letter identified item number NP462R EnduRo Special Key for Tibia Locking Ring F1 10/12mm as being removed from the market for a new version NP462RM after overall system modification. Users are instructed to 1) Review inventory and check that only the latest version (NP462RM and NP454R) are being used. 2) Contact customer service to return any affected inventory. 3) Complete and return the acknowledgement form. Questions are to be directed to Josie McBride at (610) 984-9290.

    Distribution

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

    Quantity

    67