BEUDAMED
    FDA Recall Terminated

    DePuy DNP Anatomic Fracture Repair System, JIG DNP Anatomic, Depuy, Warsaw, IN; REF DNPAJIG. The device is used in the treatment of fractures and osteotomies of the distal radius.

    Recall: Z-0982-2009 · Initiated December 23, 2008

    Recall

    Recall Number
    Z-0982-2009
    Event Number
    50700
    Firm
    Depuy Orthopaedics, Inc.
    FEI Number
    1818910
    Product Code
    HRS
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    December 23, 2008
    Posted
    February 11, 2009
    Terminated
    October 18, 2010
    Address
    700 Orthopaedic Dr, Warsaw, IN, 46582-3994

    Description

    DePuy DNP Anatomic Fracture Repair System, JIG DNP Anatomic, Depuy, Warsaw, IN; REF DNPAJIG. The device is used in the treatment of fractures and osteotomies of the distal radius.

    Reason

    The DNP nail plate may not attach to the alignment guide (jig) instrument, making it difficult to insert the nail plate into position or to drill needed holes accurately.

    Action

    The firm's sales force was instructed via "Urgent Device Correction" letter issued December 29, 2008 to inspect all of these instruments in their possession, and those instruments at their hospital customers, and to leave a copy of the letter with each hospital customer who has the instruments on site. The letter describes the issue and corrective actions for customers. Please direct questions about this recall to Depuy Orthopaedics, Inc. at 888-783-7156.

    Distribution

    Nationwide Distribution.

    Quantity

    Approx. 3,250 of all products