Recall Z-1390-05 ยท DZJ Driver, Wire, And Bone Drill, Manual
Stryker Instruments Div. of Stryker Corporation
Stryker brand Consolidated Operating Room Equipment (CORE) SystemPowered Instrument Driver, REF 5400-50; Model 5400-050-000A.
| Date | Aug 23, 2005 (initiated Aug 5, 2005) |
| Status | Terminated |
| Reason | Potential electrical shock hazard, in that the potential exists for the patient to be exposed to an earth-referenced electrical current. |
| Root cause | Other |
| Action | U.S. customer was notified via recall letter dated August 5, 2005 and international affiliates were notified via email. U.S. account was requested to return the product. |
| Quantity | 27 |
| Distribution | Virginia, Australia, Canada, England, France, Germany, Japan, Netherlands, Sweden, Switzerland, |
| 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 |