Recall Z-0825-2011 ยท HRX Arthroscope
Stryker Endoscopy
Stryker brand End Cutter Shaver Blade F-Series, 4.0 mm; Model Number -375-747-000, manufactured by Stryker Puerto Rico
| Date | Dec 28, 2010 (initiated Nov 12, 2009) |
| Status | Terminated |
| Reason | 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 | 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 | 295 units |
| Distribution | Nationwide Distribution includes: Arizona, California, Colorado, Denver, Florida, Hawaii, Illinois, Kansas, Kentucky, Massachusetts, Michigan, New York, Ohio, and South Carolina. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.