Synthes ProDisc-C Milling Bits Recalled Due to Breakage Risk

Plain-English summary

Synthes, Inc. is recalling certain lots of the 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. These spinal surgical instruments are used as part of the milling option for keel preparation of the vertebral bodies, where they are coupled to a power tool and interface with a milling guide.

The recall is being issued because certain lots of these milling bits have an increased potential to break during use. The affected products were distributed nationwide in the United States. The recall covers 6,690 units across various part numbers and lot numbers.

Healthcare providers and facilities that have these specific lots should stop using them immediately and contact Synthes, Inc. for further instructions on how to return or dispose of the affected instruments.

The recalled product

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 optio

Manufacturer

Synthes, Inc.

Category

Medical Device — Surgical Instrument

Hazard

• structural-failure
• breakage

Affected units

6,690

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

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