Triathlon Baseplate Impactor Extractor, Orthopedic manual surgical instrument, Catalog Number 6541-4-805, Non-Sterile, S
FDA device recall Z-1105-2008 · posted 2008-05-14 · Terminated
Recall details
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Reason for recall
- Insertion/Removal Difficulties: The Baseplate Impactor/Extractor may not assemble/disassemble easily to the baseplate.
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- HWA
- Quantity affected
- 293 total units
- Distribution
- Worldwide Distribution
- Date initiated
- 2005-02-23
- Date posted
- 2008-05-14
- Date terminated
- 2008-05-30
- Location
- Mahwah, NJ
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