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 milling guide, which is connected to a trial implant for the keel preparation step.
FDA Recall Z-1669-2014 · Posted 2014-05-29
Recalling FirmSynthes, Inc.
Recall StatusTerminated
Product CodeGFG
Date Initiated2014-04-29
Date Terminated2016-05-19
Product Quantity6690
Reason for Recall
Certain lots of the ProDisc-C 2.0mm Milling Bits have an increased potential to break during use.
Firm 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.
Root Cause
Process control
Distribution Pattern
US Nationwide Distribution
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.