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U.S. Department of Health and Human Services

Class 2 Device Recall Lateral Decubitus Alignment Guide

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 Class 2 Recall
Lateral Decubitus Alignment Guide
see related information
Date Posted August 27, 2009
Recall Status1 Terminated on October 15, 2009
Recall Number Z-1817-2009
Recall Event ID 52375
Product Classification Impactor - Product Code HWA
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.
Code Information Lot codes: TACFA03, TACFA0G, TACFA0M, TACF12P, & TACG104.
Recalling Firm/
Manufacturer
Stryker Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah, New Jersey 07430
For Additional Information Contact Rita Intorella
201-831-5825
Manufacturer 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.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
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.
Quantity in Commerce 61 units
Distribution Nationwide Distribution
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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