BEUDAMED
    FDA Recall Terminated

    The 2nd Assist Knee Positioner

    Recall: Z-0803-2018 · Initiated September 7, 2017

    Recall

    Recall Number
    Z-0803-2018
    Event Number
    79141
    Firm
    Zimmer Biomet, Inc.
    FEI Number
    1825034
    Product Code
    JEB
    Status
    Terminated
    Root Cause
    Package design/selection
    Initiated
    September 7, 2017
    Terminated
    August 23, 2018
    Address
    56 E Bell Dr, Warsaw, IN, 46582-6989

    Description

    The 2nd Assist Knee Positioner

    Reason

    Zimmer Biomet is conducting a medical device recall for the 2nd Assistant Knee Positioner due to the potential for the sterile packaging barrier to be breached during distribution.

    Action

    On September 12, 2017 an URGENT MEDICAL DEVICE RECALL notice was issued to distributors and customers titled "The Second Assistant Disposable Knee Positioner". The notice requests customers to review their inventory and to quarantine any remaining product, which will be returned to the firm. Also, to notify any additional accounts which may have received product from you. Questions or concerns can be directed to Customer Service at 574-371-3071

    Distribution

    Nationally

    Quantity

    38,879 units