Recall Z-1669-2014 ยท GFG Bit, Surgical
Synthes, Inc.
Synthes ProDisc-C 2.0mm Milling Bit, Synthes 2.0mm Milling Bit HXC, Synthes 2.0mm Milling Bit with 2.35mm x 33.5mm Shaft, and Synthes 2.0mm Milling Bit with Flat Coupling. Spinal surgical instrument: The Synthes ProDisc-C 2.0mm Milling Bits are used as a part of the milling option for keel preparation of the vertebral bodies. The milling bits are coupled to a power tool and interface with the mill
| Date | May 29, 2014 (initiated Apr 29, 2014) |
| Status | Terminated |
| Reason | Certain lots of the ProDisc-C 2.0mm Milling Bits have an increased potential to break during use. |
| Root cause | Process control |
| Action | DePuy Synthes sent a Recall letter, dated April 29, 2014, to affected customers. The letter identified the affected customers, problem and actions to be taken. The letter instructed customers to discontinue use and distribution of the device and to return affected devices to Synthes. For questions call 610-719-5450. |
| Quantity | 6690 |
| Distribution | US Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.