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
FDA device recall Z-1669-2014 · posted 2014-05-29 · Terminated
Recall details
- Recalling firm
- Synthes, Inc.
- Reason for recall
- Certain lots of the ProDisc-C 2.0mm Milling Bits have an increased potential to break during use.
- Action taken
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- GFG
- Quantity affected
- 6690
- Distribution
- US Nationwide Distribution
- Date initiated
- 2014-04-29
- Date posted
- 2014-05-29
- Date terminated
- 2016-05-19
- Location
- West Chester, PA
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