Recall Z-1818-2009 ยท HSB Rod, Fixation, Intramedullary And Accessories
Stryker Howmedica Osteonics Corp.
T2 Ankle Arthrodesis Nail Surgical Protocol, Catalog Number LT2AA-OT, Stryker Orthopaedics The Surgical Protocol instructs surgeons on proper surgical technique for the T2 Ankle Arthrodesis Nail.
| Date | Aug 18, 2009 (initiated Nov 17, 2006) |
| Status | Terminated |
| Reason | Operative Surgical Technique was found to have a typographical error where hyphens were inadvertently omitted in incision lengths (i.e. 1520 cm should be 15-20 cm). |
| Root cause | Labeling Change Control |
| Action | Important Product Correction Letters, dated November 17, 2006, were sent to all Stryker Branches/agencies via Federal Express. The letter stated the issue and asked consignees to examine their inventory and contact their sales reps. It also told them to destroy the affected Operative Techniques by cutting them in half and discarding them, complete the attached Acknowledgment Form, and fax a signed copy of that form to 201-831-6069. The letter stated that Stryker Orthopaedics Customer Service reps would place consignees' re-orders for the product being destroyed. Also, the letter stated tha |
| Quantity | 1270 |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051590 | T2 ANKLE ARTHRODESIS NAIL Howmedica Osteonics Corp., Jul 29, 2005 |