Long Length Dyax Nail.
FDA device recall Z-0256-06 · posted 2005-12-01 · Terminated
Recall details
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Reason for recall
- Stryker became aware that Catalog number 1594-1130S, Lot Code K559623 was manufactured with a lag screw hold angulation of 135 degrees rather than 130 degrees.
- Action taken
- The firm sent out notification letters via FedEx on 9/7/2004 with return receipt.
- Root cause
- Other
- Status
- Terminated
- Product code
- NDH
- Quantity affected
- 4
- Distribution
- The devices were distributed to Stryker branches and agencies. These are Stryker sales representatives located nationwide.
- Date initiated
- 2004-09-07
- 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 |
|---|---|---|
| LONG LENGTH DYAX NAIL (K013468) | Howmedica Osteonics Corp. | 2001-11-16 |