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Terminated

Stryker T2 Ankle Arthrodesis Nail, left; 012 x 300 mm; Catalog number: 18181230S; 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 Recall Z-0843-2010 · Posted 2010-02-24

Recall StatusTerminated
Product CodeHSB
Date Initiated2009-12-29
Date Terminated2012-08-06
Product Quantity702 total, all sizes

Reason for Recall

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

Firm Action

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.

Root Cause

Packaging

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.

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