PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: June 4, 2014 Initiated: April 29, 2014 #Z-1669-2014

Product Description

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.

Reason for Recall

Certain lots of the ProDisc-C 2.0mm Milling Bits have an increased potential to break during use.

Details

Recalling Firm
Synthes, Inc.
Units Affected
6690
Distribution
US Nationwide Distribution
Location
West Chester, PA

Frequently Asked Questions

What product was recalled? ▼
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.. Recalled by Synthes, Inc.. Units affected: 6690.
Why was this product recalled? ▼
Certain lots of the ProDisc-C 2.0mm Milling Bits have an increased potential to break during use.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 4, 2014. Severity: Moderate. Recall number: Z-1669-2014.

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