BEUDAMED
    FDA Enforcement Class II Terminated

    Product 35 consists of all product under product code: JWH and same usage: Item no: 522007300 I/B II KNEE FLUTED ROD, 1 for use in total knee arthroplasty

    Recall: Z-1133-2016 · Reported March 23, 2016

    Enforcement

    Recall Number
    Z-1133-2016
    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 35 consists of all product under product code: JWH and same usage: Item no: 522007300 I/B II KNEE FLUTED ROD, 1 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.: 62207450

    Distribution

    US Nationwide Distribution

    Quantity

    49