BEUDAMED
    FDA Enforcement Class II Terminated

    Product 52 consists of product code: HWC and same usage: Item no: 525004530 NEXGEN OSTEOTOMY CORT BON 525004540 NEXGEN OSTEOTOMY CORT BON 525006545 NEXGEN OSTEOTOMY CORT BON 525006560 NEXGEN OSTEOTOMY CORT BON 525006565 NEXGEN OSTEOTOMY CORT BON for use in total knee arthroplasty

    Recall: Z-1150-2016 · Reported March 23, 2016

    Enforcement

    Recall Number
    Z-1150-2016
    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 52 consists of product code: HWC and same usage: Item no: 525004530 NEXGEN OSTEOTOMY CORT BON 525004540 NEXGEN OSTEOTOMY CORT BON 525006545 NEXGEN OSTEOTOMY CORT BON 525006560 NEXGEN OSTEOTOMY CORT BON 525006565 NEXGEN OSTEOTOMY CORT BON 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.: 61996176 61996176N 61996177 61996177N 61687334 61926537 62308501 61811187 61996179 61996179N

    Distribution

    US Nationwide Distribution

    Quantity

    925