Wright Medical Technology, Gladiator Bipolar Hip Prosthesis, REF: GLBP-3652, Size 52mm O.D., use with 36 mm Head
FDA device recall Z-0570-2007 · posted 2007-03-07 · Terminated
Recall details
- Recalling firm
- Wright Medical Technology Inc
- Reason for recall
- Product specification failure which could result in improper locking of the cup onto the femoral head.
- Action taken
- The firm initiated the recall by telephoning its distributors on January 3, 2007 to request the return of the products. They followed with letters (mailed 1/15/07) to hospitals, implanting surgeons, and distributors requesting return of the product and informing them of the revision surgery that was a result of the problem.
- Root cause
- Other
- Status
- Terminated
- Product code
- KWY
- Quantity affected
- 12 units
- Distribution
- Nationwide and Japan
- Date initiated
- 2007-01-03
- Date posted
- 2007-03-07
- Date terminated
- 2009-01-15
- Location
- Arlington, TN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GLADIATOR BIPOLAR SYSTEM (K062693) | Wrightmedicaltechnologyinc | 2006-09-29 |