—#88337

Product

Stryker brand End Cutter Shaver Blade F-Series, 4.0 mm; Model Number -375-747-000, manufactured by Stryker Puerto Rico

FDA product code: HRX — Arthroscope
Device class: Class 2
Medical specialty: Orthopedic
Affected lot / code info: Lot Number: 09203CE2

Why it was recalled

Potential breakage of the internal shaft of the End Cutter Shaver Blade; F-Series, 4.0mm. if breakage occurs, the device becomes non-functional and the defect could be observed through the camera/console system.

Root cause (FDA determination)

Device Design

Action the firm took

Stryker issued Urgent Product Recall letters dated November 12, 2009 to all its direct consignees, informing them of the affected products and providing instructions on the recall. Customers were requested to return the product to Stryker. Stryker can be contacted concerning this recall at 408 754-2124.

Recalling firm

Firm: Stryker Endoscopy
Address: 5900 Optical Ct, San Jose, California 95138-1400

Distribution

Distribution pattern: Nationwide Distribution includes: Arizona, California, Colorado, Denver, Florida, Hawaii, Illinois, Kansas, Kentucky, Massachusetts, Michigan, New York, Ohio, and South Carolina.

Timeline

Recall initiated: 2009-11-12
Posted by FDA: 2010-12-28
Terminated: 2011-01-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #88337. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.