BEUDAMED
    FDA Enforcement Class II Terminated

    Product 12 consists of all product under product code JDI , and same usage: Item no: 902602935 6 DEGREE COCR FEM HEAD 28 902602835 6 DEGREE COCR FEM HEAD 28 902603235 6 DEGREE COCR FEM HEAD 32 902603335 6 DEGREE COCR FEM HEAD 32 902603600 6 DEGREE COCR FEM HEAD 36 902603610 6 DEGREE COCR FEM HEAD 36 902603614 6 DEGREE COCR FEM HEAD 36 Product Usage: For use in total or hemi hip arthroplasty

    Recall: Z-1110-2016 · Reported March 23, 2016

    Enforcement

    Recall Number
    Z-1110-2016
    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 12 consists of all product under product code JDI , and same usage: Item no: 902602935 6 DEGREE COCR FEM HEAD 28 902602835 6 DEGREE COCR FEM HEAD 28 902603235 6 DEGREE COCR FEM HEAD 32 902603335 6 DEGREE COCR FEM HEAD 32 902603600 6 DEGREE COCR FEM HEAD 36 902603610 6 DEGREE COCR FEM HEAD 36 902603614 6 DEGREE COCR FEM HEAD 36 Product Usage: For use in total or hemi hip 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 no62240860 62339639 62395853 62240859 62279765 62339640 62395852 62089508 62094969 62185962 62240862 62273366 62279766 61660149 62279769 62284368 62284368N 62284371 62093453

    Distribution

    US Nationwide Distribution

    Quantity

    209