Recall Z-0681-2017 ยท HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
Synthes (USA) Products LLC
Synthes 0.76 mm Drill Bit/Stryker J-Latch/with 5mm Stop/44.5 mm Non-Sterile
| Date | Dec 1, 2016 (initiated Nov 1, 2016) |
| Status | Terminated |
| Reason | Package may be incorrectly labeled as containing 0.76 mm Drill Bit, but in fact contain a 1.1 mm diameter Drill Bit. |
| Root cause | Under Investigation by firm |
| Action | DePuy Synthes sent an Urgent Notice to customers affected by the recall to inform them of the potential impacts, and actions to be taken for the return of the identified units. |
| Quantity | 84 units |
| Distribution | Distributed Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K043310 | SYNTHES (USA) ELECTRIC PEN DRIVE SYSTEM Synthes (Usa), Jan 5, 2005 |