Class 2 Device Recall End Cutter Shaver Blade FSeries, 4.0 mm

• Date Initiated by Firm: November 12, 2009
• Date Posted: December 28, 2010
• Recall Status: Terminated on January 03, 2011
• Recall Number: Z-0825-2011
• Recall Event ID: 54147
• 510(K)Number: K9413333
• Product Classification: Arthroscope - Product Code HRX
• Product: Stryker brand End Cutter Shaver Blade F-Series, 4.0 mm; Model Number -375-747-000, manufactured by Stryker Puerto Rico
• Code Information: Lot Number: 09203CE2
• Recalling Firm/ Manufacturer: Stryker Endoscopy; 5900 Optical Ct; San Jose CA 95138-1400
• For Additional Information Contact: Nila Patel ; 408-754-2124
• Manufacturer Reason for Recall: 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.
• FDA Determined Cause: Device Design
• Action: 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.
• Quantity in Commerce: 295 units
• Distribution: Nationwide Distribution includes: Arizona, California, Colorado, Denver, Florida, Hawaii, Illinois, Kansas, Kentucky, Massachusetts, Michigan, New York, Ohio, and South Carolina.
• 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.