—#87956

Product

Stryker T2 Ankle Arthrodesis Nail, right; 010 x 300 mm; Catalog number: 18191030S; Sterile, TI Alloy; Stryker Trauma GmbH, Germany; Distributed in the US by Howmedica Osteonics Corp, Mahwah, NJ. Intended for tibiotalocalcaneal arthrodesis (fusion) and to provide stabilization of the hindfoot and ankle including the transverse tarsal joints coupling the mid-foot to the hindfoot.

FDA product code: HSB — Rod, Fixation, Intramedullary And Accessories
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K051590
Affected lot / code info: lot codes: K101051, K157119, K185536, K210257, K549634, K735538, K769105, K779949, K837690, K868843, and K893064.

Why it was recalled

Stryker Orthopaedics became aware that there is the potential for damage to the sterile packaging of the product during transport.

Root cause (FDA determination)

Packaging

Action the firm took

Urgent Product Recall notification letters were sent to branches on 12/29, 2009, with a corrected version that included a list of catalog numbers and code numbers on January 11, 2009. Letters were also sent by Fed Ex on January 11, 2009 to Hospital Risk Management, Chief of Orthopaedics and surgeons who may have used the device. The letters identified the affected product, described the issue, and the hazards involved. The letter also asked customers to examine their inventory and hospital locations to identify the affected product. They are to retrieve all affected product and return it to their branch or agency warehouse for reconciliation. Customers are to reconcile all products utilizing the Product Recall Accountability Form. Questions should be directed to 201-972-2100.

Recalling firm

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

Distribution

Distribution pattern: Nationwide Distribution.

Timeline

Recall initiated: 2009-12-29
Posted by FDA: 2010-02-24
Terminated: 2012-08-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #87956. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.