Class 2 Device Recall ACE trochanteric nail systems

• Date Initiated by Firm: December 11, 2003
• Date Posted: January 31, 2004
• Recall Status: Terminated on April 15, 2004
• Recall Number: Z-0481-04
• Recall Event ID: 27923
• 510(K)Number: K010780
• Product Classification: Rod, Fixation, Intramedullary And Accessories - Product Code HSB
• Product: Depuy brand ACE trochanteric nail anti-rotation/ superior screw; sterile, 85 mm; Product 903205085.
• Code Information: All.
• Recalling Firm/ Manufacturer: Depuy Orthopaedics, Inc.; 700 Orthopaedic Dr; Warsaw IN 46582-3994
• For Additional Information Contact: 800-366-8143
• Manufacturer Reason for Recall: The lag screw may migrate to the femoral head or into the abdominal cavity.
• FDA Determined Cause: Other
• 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = HSB