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U.S. Department of Health and Human Services

Class 2 Device Recall ACE trochanteric nail systems

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  Class 2 Device Recall ACE trochanteric nail systems see related information
Date Initiated by Firm December 11, 2003
Date Posted January 31, 2004
Recall Status1 Terminated 3 on April 15, 2004
Recall Number Z-0490-04
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; non-sterile, 5 mm x 85 mm; Product 903005085.
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 2
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 and Original Applicant = DEPUY ORTHOPAEDICS, INC.
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