Synthes 0.76 mm Drill Bit/Stryker J-Latch/with 5mm Stop/44.5 mm Non-Sterile
FDA device recall Z-0681-2017 · posted 2016-12-01 · Terminated
Recall details
- Recalling firm
- Synthes (USA) Products LLC
- Reason for recall
- Package may be incorrectly labeled as containing 0.76 mm Drill Bit, but in fact contain a 1.1 mm diameter Drill Bit.
- Action taken
- 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.
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- HWE
- Quantity affected
- 84 units
- Distribution
- Distributed Nationwide
- Date initiated
- 2016-11-01
- Date posted
- 2016-12-01
- Date terminated
- 2017-06-01
- Location
- West Chester, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SYNTHES (USA) ELECTRIC PEN DRIVE SYSTEM (K043310) | Synthes (Usa) | 2005-01-05 |