Recall Z-0786-05 ยท HRX Arthroscope
Stryker Endoscopy
Stryker Brand 5.5mm 6 Flute Barrel Bur, Model Number: 375-951-000; Product is distributed by Stryker Endoscopy, 5900 Optical Court, San Jose, CA 95138
| Date | May 3, 2005 (initiated Feb 8, 2005) |
| Status | Terminated |
| Reason | The device has the potential to overheat and cause patient burns during use. |
| Root cause | Process control |
| Action | All consignees will be immediately notified via phone calls and a mailed Urgent Product Recall Notice (2 recipients per consignee, Risk Manager and OR Supervisor) |
| Quantity | 28935 boxes, 5 units per box. |
| Distribution | 740 domestic consignees |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.