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U.S. Department of Health and Human Services

Class 2 Device Recall Triathlon Baseplate Impactor Extractor

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 Class 2 Recall
Triathlon Baseplate Impactor Extractor
see related information
Date Posted May 14, 2008
Recall Status1 Terminated on May 30, 2008
Recall Number Z-1105-2008
Recall Event ID 46331
Product Classification Impactor - Product Code HWA
Product Triathlon Baseplate Impactor Extractor, Orthopedic manual surgical instrument, Catalog Number 6541-4-805, Non-Sterile, Stryker Howmedica Osteonics Corp, Mahwah, NJ 07430
Code Information Catalog Number 6541-4-805 Lot Code NYC08
Recalling Firm/
Manufacturer
Stryker Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah, New Jersey 07430-2002
For Additional Information Contact Larry Ross
201-831-5972
Manufacturer Reason
for Recall
Insertion/Removal Difficulties: The Baseplate Impactor/Extractor may not assemble/disassemble easily to the baseplate.
FDA Determined
Cause 2
DESIGN: Device Design
Action Consignees were notified via an Important Market Withdrawal Letter sent 2/25/05. The letter instructed users to fax a Product Accountability Form to the recalling firm identifying any affected products and to return them to the firm. The letter informed users that the products will be reworked and returned at a later date. The letter also identified other products that could be used as replacements. For additional information, contact 201-831-5825 or 201-831-5110.
Quantity in Commerce 293 total units
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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