Recall Z-0060-06 ยท HSB Rod, Fixation, Intramedullary And Accessories
Stryker Howmedica Osteonics Corp.
T2 Recon Nail System.
| Date | Oct 15, 2005 (initiated Aug 12, 2005) |
| Status | Terminated |
| Reason | The blister pack containing the Recon 6.5 Lag Screws may become damage during shipment resulting in loss of sterility. |
| Root cause | Other |
| Action | The notification letters and product accountability forms were sent via FedEx on 8/12/2005 with return receipt. |
| Quantity | 4698 PIECES |
| Distribution | The devices have been distributed to Stryker Branches/Agencies, Hospitals nationwide, and Government hospitals. There are no international customers. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K032898 | T2 RECON NAIL SYSTEM Howmedica Osteonics Corp., Oct 9, 2003 |