BEUDAMED
    FDA Enforcement Class II 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 · Reported November 15, 2017

    Enforcement

    Recall Number
    Z-0070-2018
    Event ID
    78299
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Zimmer Biomet, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    November 15, 2017
    Initiation Date
    April 25, 2017
    Classification Date
    November 8, 2017
    Termination Date
    February 6, 2018
    Address
    56 E Bell Dr, N/A, Warsaw, IN, 46582-6989, United States

    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.

    Code Info

    Part Number: CP116574 Lot Number: 073840

    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