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.
FDA Recall Z-1818-2009 · Posted 2009-08-18
Recalling FirmStryker Howmedica Osteonics Corp.
Recall StatusTerminated
Product CodeHSB
Date Initiated2006-11-17
Date Terminated2009-08-20
Product Quantity1270
Reason for Recall
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).
Firm 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 that in the interim a correct revision of the Operative Technique could be found online. Customers are to contact Dave O'Dell at 201-831-5277 or Rita Intorrella at 201-831-5825 with any questions.
Root Cause
Labeling Change Control
Distribution Pattern
Nationwide Distribution
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.