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U.S. Department of Health and Human Services

Class 2 Device Recall Triathlon AR 4:1 Cutting Blocks

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 Class 2 Recall
Triathlon AR 4:1 Cutting Blocks
see related information
Date Posted August 26, 2009
Recall Status1 Terminated on October 15, 2009
Recall Number Z-1916-2009
Recall Event ID 52641
Product Classification Orthopedic Manual Surgical Instrument - Product Code LXH
Product Triathlon AR 4:1 Cutting Blocks - Size 1-8; Catalog Numbers: 6541-0-701, 6541-0-702, 6541-0-703, 6541-0-704, 6541-0-705, 6541-0-706, 6541-0-707, & 6541-0-708; Triathlon MIS Instruments; Non Sterile Stryker Orthopaedics 325 Corporate Drive Mahwah, NJ 07430 The Triathlon AR 4:1 Cutting Blocks and the Triathlon MIS 4:1 Cutting Blocks are used to prepare the Femur (bone cuts) for the Triathlon femoral component.
Code Information Catalog no. 6541-0-701, 6541-0-702, 6541-0-703, 6541-0-704, 6541-0-705, 6541-0-706, 6541-0-707, 7541-0-708. All lot codes.
Recalling Firm/
Manufacturer
Stryker Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah, New Jersey 07430
For Additional Information Contact Rita Intorella
201-831-5000
Manufacturer Reason
for Recall
Triathlon Cutting Blocks did not assemble to the Triathlon Impactor/Extractor Handle.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
Action Important Product Correction letters were sent to all branches/agencies on February 12, 2008 by Federal Express. The letter asked consignees to examine their inventory and hospital locations to identify the affected product. Customers were asked to perform a functional inspection by assembling the Triathlon Impactor/Extractor Handle to all of their MIS Cutting Blocks. If the cutting block does not assemble, customers are to list the affected lot codes on the Attached Product Accountability Form and fax a copy to (201) 831-6069. The letter states that product should not be returned until further instructions are received. Questions should be directed to (201) 831-5825.
Quantity in Commerce 690 total units - both varieties
Distribution Worldwide 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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