BEUDAMED
    FDA Recall Terminated

    Custom Ti MAK RS OSS Segmental Femoral Rotating Hinged Knee. This Rotating Hinged Knee is intended to replace patient anatomy.

    Recall: Z-0070-2018 · Initiated April 25, 2017

    Recall

    Recall Number
    Z-0070-2018
    Event Number
    78299
    Firm
    Zimmer Biomet, Inc.
    FEI Number
    1825034
    Product Code
    KRO
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    April 25, 2017
    Terminated
    February 6, 2018
    Address
    56 E Bell Dr, Warsaw, IN, 46582-6989

    Description

    Custom Ti MAK RS OSS Segmental Femoral Rotating Hinged Knee. This Rotating Hinged Knee is intended to replace patient anatomy.

    Reason

    A custom implant manufactured entirely from titanium for a patient with a nickel allergy was requested by a surgeon. After the device was manufactured and used in the planned surgery, it was discovered internally that the implant assembly had a CoCrMo screw included as a component of the implant, which contains nickel.

    Action

    The firm contacted the surgeon who received / implanted the device. The product has been implanted, so it is not subject to being returned.

    Distribution

    This was a custom implant, there was only one (1) unit manufactured and distributed. The product has been implanted, so it is not subject to being returned.

    Quantity

    1