—#82807

Product

Lateral Decubitus Alignment Guide, Non Sterile; manual surgical instrument. The MIS Hip Acetabular instrument set includes the curved positioner/impactor, supine alignment guide, and decubitus alignment guide. Catalog No. 1440-1370 Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430. Authorized Representative in Europe: Stryker France, Cedex France. The correct position of the cup relative to the pelvic reference planes can be achieved by the use of the alignment guide.

FDA product code: HWA — Impactor
Device class: Class 1
Medical specialty: Orthopedic
Affected lot / code info: Lot codes: TACFA03, TACFA0G, TACFA0M, TACF12P, & TACG104.

Why it was recalled

The Lateral Decubitus Alignment Guide either did not assemble to its mating part, the Curved Impaction Handle, or partially engages the handle, but does not fully lock.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

Important Market Withdrawal Letters were sent to Stryker Branches on April 27, 2006 vis Federal Express. The letter asked consignees to examine their inventory and identify the product. They are to retrieve all affected product lots and return to their branch or agency warehouse for reconciliation. Also, they are to reconcile all product on the attached Product Accountability Form and fax a copy. Affected should be returned and their Stryker Orthopaedics Customer Service Rep should be contacted to re-order the product that is being returned as part of this recall. Questions should be referred to Rita Intorella at 201-831-5825.

Recalling firm

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

Distribution

Distribution pattern: Nationwide Distribution

Timeline

Recall initiated: 2006-04-27
Posted by FDA: 2009-08-27
Terminated: 2009-10-15
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #82807. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.