BEUDAMED
    FDA Recall Terminated

    NS357R Vega PS Tibia Trial/Preparation Plateau size T4 (Component of the Vega Knee System Set #ST0468) The affected part is provided in the Vega Knee System Set #ST0468. The Vega Knee System is used for reconstruction of the diseased knee joint.

    Recall: Z-0591-2018 · Initiated August 10, 2017

    Recall

    Recall Number
    Z-0591-2018
    Event Number
    79042
    Firm
    Aesculap Implant Systems LLC
    FEI Number
    2916714
    Product Code
    HWT
    Status
    Terminated
    Root Cause
    Mixed-up of materials/components
    Initiated
    August 10, 2017
    Posted
    February 12, 2018
    Terminated
    August 8, 2018
    Address
    3773 Corporate Pkwy, Center Valley, PA, 18034-8217

    Description

    NS357R Vega PS Tibia Trial/Preparation Plateau size T4 (Component of the Vega Knee System Set #ST0468) The affected part is provided in the Vega Knee System Set #ST0468. The Vega Knee System is used for reconstruction of the diseased knee joint.

    Reason

    The NS357R Vega PS Tibia Trial/Preparation Plateau size T4 may be incorrectly labeled. If the incorrect size trial is used the potential risk is implantation of the incorrect implant size which may lead to injury of ligaments, pain and possible revision surgery.

    Action

    On August 21, 2017 an Urgent Medical Device Recall notification was issued titled "NS357R Tibia Trial Plateau" asking distributors to inspect Sets #0468 and follow the inspection instructions on the customer notification letter and immediately remove the affected part and return to Aesculap Implant Systems. Questions or concerns can be directed to Customer Service at 314-551-5998

    Distribution

    USA (nationwide)

    Quantity

    13 Units