Gamma3 Long Nail Kit, 120 degree, 11 x 320mm Right. And 125 degree Nail.
FDA device recall Z-0241-06 · posted 2005-12-01 · Terminated
Recall details
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Reason for recall
- The Gamma Nail may have been manufactured with an incorrect lag screw hole angulation. Catalog number 3225-0360S, lot code K949396 was manufactured with a lag screw hole angulation of 120 degrees instead of 125 degrees. Catalog number 3220-0320S, lot code K949408 was manufactured with a lag screw hole angulation of 125 degrees instead of 120 degrees.
- Action taken
- Notification letters and Product Accountability forms were sent via FedEx on 11/22/2004 with return receipt.
- Root cause
- Other
- Status
- Terminated
- Product code
- NDH
- Quantity affected
- 19
- Distribution
- The product was sent to Stryker Orthopaedics branches and agents throughout the US. There was one hospital that was a direct account.
- Date initiated
- 2004-11-22
- Date posted
- 2005-12-01
- Date terminated
- 2006-10-03
- Location
- Mahwah, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GAMMA3 NAIL SYSTEM (K034002) | Howmedica Osteonics Corp. | 2004-01-15 |