Recall Z-0478-04 ยท HSB Rod, Fixation, Intramedullary And Accessories
Depuy Orthopaedics, Inc.
Depuy brand ACE trochanteric nail anti-rotation/ superior screw; sterile, 70 mm; Product 903205070.
| Date | Jan 31, 2004 (initiated Dec 11, 2003) |
| Status | Terminated |
| Reason | The lag screw may migrate to the femoral head or into the abdominal cavity. |
| Root 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 R |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K010780 | TROCHANTERIC NAIL DePuy Orthopaedics, Inc., Jun 12, 2001 |