Profemur R, Revision Hip system, Proximal Body (part), X-Small model, REF: PPW38364, Cementless, Titanium Plasma Spray C
FDA device recall Z-0867-2007 · posted 2007-06-07 · Terminated
Recall details
- Recalling firm
- Wright Medical Technology Inc
- Reason for recall
- The titanium plasma coating was found to have missing fragments.
- Action taken
- The firm sent out recall notices to implanting surgeons by letter dated 03/27/2007 (via FedEx) to notify the surgeons of the issue. The hospitals and distributors were also notified of the issue and given instructions for return of the product.
- Root cause
- Other
- Status
- Terminated
- Product code
- LZO
- Quantity affected
- 18 units
- Distribution
- Nationwide, Puerto Rico, & Japan
- Date initiated
- 2007-03-27
- Date posted
- 2007-06-07
- Date terminated
- 2008-06-30
- 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 |
|---|---|---|
| PRO-FEMUR R (K003016) | Wrightmedicaltechnologyinc | 2000-12-13 |