Recall Z-0263-2010 ยท DZI Drill, Bone, Powered
Stryker Instruments Div. of Stryker Corporation
Stryker Instruments 2.1 mm Cross-Cut Fissure Bur, carbide extended, sterile; REF 2296-101-621.
| Date | Nov 16, 2009 (initiated Oct 5, 2009) |
| Status | Terminated |
| Reason | The cross-cuts are missing on the device, which will result in poor cutting and overheating and/or smoking of the device. |
| Root cause | Vendor change control |
| Action | Consignees were notified by letter dated 10/5/09 and requested to return the devices to Stryker. The international account was notified by email. |
| Quantity | 93 |
| Distribution | USA (California, Georgia, Louisiana, Ohio, Wisconsin) and Brazil. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K040369 | STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM Stryker Instruments, Apr 1, 2004 |