—#82813

Product

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 product code: HSB — Rod, Fixation, Intramedullary And Accessories
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K051590
Affected lot / code info: n/a

Why it was recalled

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 (FDA determination)

Labeling Change Control

Action the firm took

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.

Recalling firm

Firm: Stryker Howmedica Osteonics Corp.
Address: 325 Corporate Dr, Mahwah, New Jersey 07430

Distribution

Distribution pattern: Nationwide Distribution

Timeline

Recall initiated: 2006-11-17
Posted by FDA: 2009-08-18
Terminated: 2009-08-20
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #82813. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.