Stryker brand End Cutter Shaver Blade F-Series, 4.0 mm; Model Number -375-747-000, manufactured by Stryker Puerto Rico
FDA device recall Z-0825-2011 · posted 2010-12-28 · Terminated
Recall details
- Recalling firm
- Stryker Endoscopy
- 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.
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- HRX
- Quantity affected
- 295 units
- Distribution
- Nationwide Distribution includes: Arizona, California, Colorado, Denver, Florida, Hawaii, Illinois, Kansas, Kentucky, Massachusetts, Michigan, New York, Ohio, and South Carolina.
- Date initiated
- 2009-11-12
- Date posted
- 2010-12-28
- Date terminated
- 2011-01-03
- Location
- San Jose, CA
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