—#90708

Product

Howmedica Osteonics Corp., Stryker Orthopaedics Passport A.R. Knee Instrumentation Anterior Skim Guide; Catalog Number 7650-5003.

FDA product code: LXH — Orthopedic Manual Surgical Instrument
Device class: Class 1
Medical specialty: Orthopedic
Affected lot / code info: Catalog Number 7650-5003; all lots.

Why it was recalled

One of the two posts on the Anterior Resection Guide could disassociate from the main body of the part which has been determined to be caused by a fracture weld.

Root cause (FDA determination)

Device Design

Action the firm took

Stryker Urgent Product Recall letters dated April 5, 2010, were sent out via Federal Express to Stryker branches/agencies, Hospital Risk Management, hospital Chief of Orthopedics and Surgeons. All hospitals and surgeons that used the product in the last year were notified. Questions and/or concerns should be directed to Rich Wolyn at 201-972-2100.

Recalling firm

Firm: Stryker Howmedica Osteonics Corp.
Address: 325 Corporate Drive, Mahwah, New Jersey 07430

Distribution

Distribution pattern: Worldwide distribution: USA, Ireland, Germany, Sweden, The Netherlands, France, Italy, Switzerland, South Africa, United Kingdom, Japan, Argentina, Mexico, Miramar (city), China, Taiwan, India, Australia, Korea, New Zealand, Malaysia, Singapore, and Canada.

Timeline

Recall initiated: 2010-04-05
Posted by FDA: 2010-08-02
Terminated: 2012-08-28
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #90708. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.