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Synthes, Inc. recalls 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
Recalled June 4, 2014 · FDA recall Z-1669-2014 · Synthes
Hazard
Certain lots of the ProDisc-C 2.0mm Milling Bits have an increased potential to break during use. · FDA Class II
Units
6690
Sold at
US Nationwide Distribution
Description
Certain lots of the ProDisc-C 2.0mm Milling Bits have an increased potential to break during use.
Product
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.
Manufacturer(s)
Synthes, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →