—#67193

Product

Triathlon Baseplate Impactor Extractor, Orthopedic manual surgical instrument, Catalog Number 6541-4-805, Non-Sterile, Stryker Howmedica Osteonics Corp, Mahwah, NJ 07430

FDA product code: HWA — Impactor
Device class: Class 1
Medical specialty: Orthopedic
Affected lot / code info: Catalog Number 6541-4-805 Lot Code NYC08

Why it was recalled

Insertion/Removal Difficulties: The Baseplate Impactor/Extractor may not assemble/disassemble easily to the baseplate.

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: Stryker Howmedica Osteonics Corp.
Address: 325 Corporate Dr, Mahwah, New Jersey 07430-2002

Distribution

Distribution pattern: Worldwide Distribution

Timeline

Recall initiated: 2005-02-23
Posted by FDA: 2008-05-14
Terminated: 2008-05-30
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #67193. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.