Stryker brand End Cutter Shaver Blade F-Series, 4.0 mm; Model Number -375-747-000, manufactured by Stryker Puerto Rico
This recall has been terminated (originally issued December 28, 2010).
- Company
- Stryker Endoscopy
- Recall Initiated
- November 12, 2009
- Posted
- December 28, 2010
- Terminated
- January 3, 2011
- Recall Number
- Z-0825-2011
- Quantity
- 295 units
- Firm Location
- San Jose, CA
- Official Source
- View on FDA website ↗
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.
Distribution
Nationwide Distribution includes: Arizona, California, Colorado, Denver, Florida, Hawaii, Illinois, Kansas, Kentucky, Massachusetts, Michigan, New York, Ohio, and South Carolina.
Lot / Code Info
Lot Number: 09203CE2
Root Cause
Device Design
Action Taken
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.