Class 2 Device Recall Triathlon Baseplate Impactor Extractor

• Date Initiated by Firm: February 23, 2005
• Date Posted: May 14, 2008
• Recall Status: Terminated on May 30, 2008
• Recall Number: Z-1105-2008
• Recall Event ID: 46331
• Product Classification: Orthopedic manual surgical instrument - 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 NJ 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: 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 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.