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Terminated

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 Recall Z-1817-2009 · Posted 2009-08-27

Recall StatusTerminated
Product CodeHWA
Date Initiated2006-04-27
Date Terminated2009-10-15
Product Quantity61 units

Reason for Recall

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.

Firm Action

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.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Nationwide Distribution

Official Source

View FDA Recall →

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

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