BEUDAMED
    FDA Recall Terminated

    Depuy PFC Oval Dome Patella (Part Number 960100)3-Peg, 32 mm, sterile; REF 96-0100.

    Recall: Z-0057-2007 · Initiated September 14, 2006

    Recall

    Recall Number
    Z-0057-2007
    Event Number
    36348
    Firm
    Depuy Orthopaedics, Inc.
    FEI Number
    1818910
    Product Code
    JWH
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 14, 2006
    Posted
    October 21, 2006
    Terminated
    April 26, 2007
    Address
    700 Orthopaedic Dr, Warsaw, IN, 46582-3994

    Description

    Depuy PFC Oval Dome Patella (Part Number 960100)3-Peg, 32 mm, sterile; REF 96-0100.

    Reason

    Mislabeled: units containing a size 32 mm. patella were labeled as a 38 mm patella.

    Action

    The firm called their sales staff on 9/14/06 and instructed them to place a hold on the product, which entails pulling products from their own inventory and at any hospitals where it has been placed on consignment. Sales staff immediately visited hospital accounts and switched out the recalled lot for other product.

    Distribution

    Nationwide.

    Quantity

    9