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Terminated

Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.

FDA Recall Z-2016-2012 · Posted 2012-07-16

Recalling FirmStryker Howmedica Osteonics Corp.
Recall StatusTerminated
Product CodeHSB
Date Initiated2012-01-26
Date Terminated2013-07-17
Product Quantity532 units.

Reason for Recall

Stryker has become aware that there exists a potential for breach of the sterile barrier of packaging associated with certain lots of T2 Knee Arthrodesis Nails.

Firm Action

Stryker Orthopaedics sent Recall letters/Customer Response forms dated 1/26/2012 and 1/30/2012 on 1/27/2012 and 1/31/2012 via FEDEX to their branches, hospitals and surgeon accounts respectively. The letter identified the product, the problem, and the aciton to be taken by the customer. Customers were instructed to contact their Stryker representative to arrange for return of any affected product. Customers were asked to fax back the attached Product Recall Acknowledgment Form as soon as possible to 201-831-6069.. For any questions customers should call 201-972-2100. For questions regarding this recall 201-831-5970.

Root Cause

Packaging

Distribution Pattern

Nationwide.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K020384T2 ARTHRODESIS NAIL SYSTEMHowmedica Osteonics Corp. · 2002-05-06

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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