BEUDAMED
    FDA Recall Terminated

    Depuy P.F.C. E Knee System Stabilized Plus Tibial Insert (STAB PLUS), 71 mm M/L, 47 mm A/P, 25 mm, 3, UHMWPE, sterile; Product Code/REF 96-2736.

    Recall: Z-0427-2008 · Initiated September 27, 2007

    Recall

    Recall Number
    Z-0427-2008
    Event Number
    44893
    Firm
    Depuy Orthopaedics, Inc.
    FEI Number
    1818910
    Product Code
    NJL
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    September 27, 2007
    Posted
    December 6, 2007
    Terminated
    April 30, 2008
    Address
    700 Orthopaedic Dr, Warsaw, IN, 46582-3994

    Description

    Depuy P.F.C. E Knee System Stabilized Plus Tibial Insert (STAB PLUS), 71 mm M/L, 47 mm A/P, 25 mm, 3, UHMWPE, sterile; Product Code/REF 96-2736.

    Reason

    An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.

    Action

    Consignee hospitals and implanting physicians were notified of the recall via an Urgent Information-Recall Notice letter and Dear Doctor letters dated 9/27/07. The hospitals were instructed to determine whether they had any of the recalled products and to contact their sales representative to pick up the product. Depuy sales representatives were notified to collect the products from consignee hospitals via email on 10/1/07. The decision to discuss this product defect with patients who had already been implanted was left to the implanting physicians.

    Distribution

    Nationwide.

    Quantity

    12