BEUDAMED
    FDA Recall Terminated

    VerSys Hip System, Beaded Fullcoat Stems, Zimmer, Inc., Warsaw, IN 46581

    Recall: Z-1842-2014 · Initiated May 19, 2014

    Recall

    Recall Number
    Z-1842-2014
    Event Number
    68339
    Firm
    Zimmer, Inc.
    FEI Number
    1000220733
    Product Code
    LPH
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    May 19, 2014
    Posted
    June 20, 2014
    Terminated
    March 24, 2015
    Address
    1800 W Center St, Warsaw, IN, 46580-2304

    Description

    VerSys Hip System, Beaded Fullcoat Stems, Zimmer, Inc., Warsaw, IN 46581

    Reason

    During routine inspection, beaded hip stem forgings received from supplier failed to meet ZES 2A-102. Processing of Beaded CoCrMo Alloy Hip Stem, material requirements per ATS #14-04818 and ATS #14-05549, respectively.

    Action

    On 6/2/2014 the firm sent "Urgent Medical Device Recall" letters to their customers. On 8/13/14, Zimmer contacted a distributor via phone pertaining to one additional lot (00-7843-011-06; lot 62547211) which had been included in the recall. Formal recall notices were issued to the distributor via email on 8/15/14.

    Distribution

    Worldwide Distribution-USA (nationwide) including the states of AL, AZ, CA, CO, CT, FL, GA, IL, IN, MA, MI, MN, NC, ND, NJ, NY, OH, OK, PA, TN, TX, VA & WI, and the countries of Canada, Colombia, Dominican Republic, Japan, Korea (S. Korea), Peru, Taiwan & Thailand.

    Quantity

    147 units