T2 Recon Nail System.
FDA device recall Z-0060-06 · posted 2005-10-15 · Terminated
Recall details
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Reason for recall
- The blister pack containing the Recon 6.5 Lag Screws may become damage during shipment resulting in loss of sterility.
- Action taken
- The notification letters and product accountability forms were sent via FedEx on 8/12/2005 with return receipt.
- Root cause
- Other
- Status
- Terminated
- Product code
- HSB
- Quantity affected
- 4698 PIECES
- Distribution
- The devices have been distributed to Stryker Branches/Agencies, Hospitals nationwide, and Government hospitals. There are no international customers.
- Date initiated
- 2005-08-12
- Date posted
- 2005-10-15
- Date terminated
- 2006-07-20
- 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 |
|---|---|---|
| T2 RECON NAIL SYSTEM (K032898) | Howmedica Osteonics Corp. | 2003-10-09 |