BEUDAMED
    FDA Recall Terminated

    DYNASTY A-CLASS POLY LINER, REF DLXP-LD36, 1 EACH, Rx ONLY, STERILE EO, GROUP D, I.D. 36 mm, LIP 15o, LINER STD, Wright Medical Technology, 4677 Airline Road, Arlington, TN 38002. Product is used in total hip arthroplasty.

    Recall: Z-2212-2010 · Initiated June 7, 2010

    Recall

    Recall Number
    Z-2212-2010
    Event Number
    56131
    Firm
    Wright Medical Technology Inc
    FEI Number
    1043534
    Product Code
    JDL
    Status
    Terminated
    Root Cause
    Software design (manufacturing process)
    Initiated
    June 7, 2010
    Posted
    August 12, 2010
    Terminated
    May 31, 2011
    Address
    5677 Airline Rd, Arlington, TN, 38002

    Description

    DYNASTY A-CLASS POLY LINER, REF DLXP-LD36, 1 EACH, Rx ONLY, STERILE EO, GROUP D, I.D. 36 mm, LIP 15o, LINER STD, Wright Medical Technology, 4677 Airline Road, Arlington, TN 38002. Product is used in total hip arthroplasty.

    Reason

    The inner and outer product packaging was missing the following information: shelf life, translations, manufacturing date, CE marking and also listed the incorrect sterilization method.

    Action

    On 06/28/2010, Wright Medical Technology sent a letter to consignees. Consignees were instructed to examine their inventory for recalled product and return it to the firm. Consignees should contact customer service at 800-238-7117 for return instructions and replacement inventory. Questions concerning the recall should be directed to Debby Daurer at 800-874-5630.

    Distribution

    USA distirbution only, in states of WI, WV, IN, IA, and GA

    Quantity

    6 units