BEUDAMED
    FDA Recall Terminated

    Depuy brand ACE trochanteric nail; sterile, long, right hip, 340 x 13 x 130; Product 926213340.

    Recall: Z-0416-04 · Initiated December 11, 2003

    Recall

    Recall Number
    Z-0416-04
    Event Number
    27923
    Firm
    Depuy Orthopaedics, Inc.
    FEI Number
    1818910
    Product Code
    HSB
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 11, 2003
    Posted
    January 31, 2004
    Terminated
    April 15, 2004
    Address
    700 Orthopaedic Dr, Warsaw, IN, 46582-3994

    Description

    Depuy brand ACE trochanteric nail; sterile, long, right hip, 340 x 13 x 130; Product 926213340.

    Reason

    The lag screw may migrate to the femoral head or into the abdominal cavity.

    Action

    Recall letters dated 12/15/03 were issued to receiving hospitals. Hospitals were instructed to cease implantation, quarantine stocks, and to notify implanting physicians to monitor their patients.

    Distribution

    United States, Austria, Australia, Belgium, Czech Republic, Egypt, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Malaysia, Netherlands, New Zealand, Norway, Pakistan, Portugal, Repulic of Korea, Singapore, South Africa, Spain, Sri Lanka, Sweden, Switzerland, United Arab Republic and the United Kingdom.