BEUDAMED
    FDA Enforcement Class II Terminated

    Product 61 consists of all product under product code: JWH and same usage: Item no: 598003712 STD PRECOAT TIBIA PLATE S for use in total knee arthroplasty

    Recall: Z-1159-2016 · Reported March 23, 2016

    Enforcement

    Recall Number
    Z-1159-2016
    Event ID
    72900
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Zimmer Manufacturing B.V.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 23, 2016
    Initiation Date
    January 11, 2016
    Classification Date
    March 12, 2016
    Termination Date
    April 13, 2017
    Address
    Turpeaux Industrial Park Rd 1 km 123.4, Mercedita, PR, 00715, United States

    Description

    Product 61 consists of all product under product code: JWH and same usage: Item no: 598003712 STD PRECOAT TIBIA PLATE S for use in total knee arthroplasty

    Reason

    As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.

    Code Info

    lot no.: 61678240 61838251 61838252 61838253 61838254 61901158 61901159 61925016 61926797 61958844 61958845 61999206 61999207 62037903 62037904 62037905 62070148 62070149 62141260 62170961 62191179 62220224 62232384 62245104 62284609 62298550 62298551 62313021 62319305 62326309 62359946

    Distribution

    US Nationwide Distribution

    Quantity

    39