BEUDAMED
    FDA Recall Terminated

    CONSERVE, TOTAL A-CLASS HEAD W/BFH TECH., REF 38AM-3635, O.D. Size: 36mm, Neck Length: +3.5mm, Taper: SLT, Sterile R, 1 each, Rx only, Wright Medical Technology, Inc., 5677 Airline, Road, Arlington, TN 38002. The CONSERVE Total Femoral Head is indicated for use in total hip arthroplasty for reduction of relief of pain and/or improved hip function in skeletally mature patients.

    Recall: Z-1716-2009 · Initiated May 14, 2009

    Recall

    Recall Number
    Z-1716-2009
    Event Number
    52217
    Firm
    Wright Medical Technology Inc
    FEI Number
    1043534
    Product Code
    JDL
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    May 14, 2009
    Terminated
    December 9, 2009
    Address
    5677 Airline Rd, Arlington, TN, 38002

    Description

    CONSERVE, TOTAL A-CLASS HEAD W/BFH TECH., REF 38AM-3635, O.D. Size: 36mm, Neck Length: +3.5mm, Taper: SLT, Sterile R, 1 each, Rx only, Wright Medical Technology, Inc., 5677 Airline, Road, Arlington, TN 38002. The CONSERVE Total Femoral Head is indicated for use in total hip arthroplasty for reduction of relief of pain and/or improved hip function in skeletally mature patients.

    Reason

    Incorrect packaging, swapped sizes

    Action

    Wright Medical Technology, Inc. notified hospitals, surgeons and their distributors of the recall situation via an "Urgent: Medical Device Voluntary Recall" notice dated May 14, 2009 explaining the problem, the hazard involved and requesting confirmation that the product was removed from their inventory. The letter included a "Fax Back" response page to ensure the receipt of the notice. For further questions, contact Wright Medical Technologies, Inc. at 1-800-874-5630.

    Distribution

    Worldwide Distribution -- Including states of NC, TN, IA, IN, MD, WI, WV, OK, WA, PA, TN, TX, FL and CA and country of Canada.

    Quantity

    15 units