Depuy brand ACE trochanteric nail; sterile, long, left hip, 360 x 9 x 130; Product 925209360.
FDA device recall Z-0392-04 · posted 2004-01-31 · Terminated
Recall details
- Recalling firm
- Depuy Orthopaedics, Inc.
- Reason for recall
- The lag screw may migrate to the femoral head or into the abdominal cavity.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- HSB
- 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, Portu
- Date initiated
- 2003-12-11
- Date posted
- 2004-01-31
- Date terminated
- 2004-04-15
- Location
- Warsaw, IN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LONG TROCHANTERIC NAIL SYSTEM (K013563) | DePuy Orthopaedics, Inc. | 2001-12-27 |