Synthes ProDisc-C Milling Bits Recalled Due to Breakage Risk
Synthes, Inc. is recalling specific lots of ProDisc-C 2.0mm Milling Bits because they have an increased potential to break during use.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a surgical instrument breaking during use, which poses a risk of harm to patients, but no specific injuries or illnesses are reported in the source text.
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…
- Manufacturer
- Synthes, Inc.
- 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.
Lot numbers (20)
- part number: 03.820.161s
- with lot numbers: 5742507
- 5755970
- 5755971
- 5755972
- 5755973
- 5755974
- 5828298
- 6336115
- 6338099
- 6338100
- 6340029
- 6340030
- 6344199
- 6344200
- 6363601
- 6385892
- 6407046
- 6431260
- 6431261
Distribution
Distributed nationwide across the United States.
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