Synthes Cranial Flap Tube Clamp Recalled for Incorrect MR Safe Labeling
Synthes (USA) Products LLC is recalling Cranial Flap Tube Clamps and Crimping Devices because they were labeled MR Safe without required testing protocols.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves incorrect labeling regarding MRI safety without reported injuries or illnesses, fitting the criteria for a moderate severity labeling error.
Plain-English summary
Synthes (USA) Products LLC is recalling the Synthes Cranial Flap Tube Clamp and Crimping Device. The product is intended to reattach a cranial bone flap to the surrounding cranium after a craniotomy procedure.
The recall was initiated because the devices were labeled as MR Safe, but they do not have the testing protocols currently required to designate them as MR Safe. The affected products were distributed US Nationwide and internationally, including Canada.
The recall involves 105,882 units. Affected part numbers include 329.315, 460.001, 460.001.01S, 460.002, 460.002.01S, 460.003, 460.003.01S, 460.008, 460.008.01S, 460.009, 460.009.01S, 460.010, 460.010.01S, 460.100, 460.100.01S, and 460.107, 460.107.01S. The source text lists numerous specific lot numbers associated with these part numbers.
The recalled product
- Product
- Synthes Cranial Flap Tube Clamp and Crimping Device Product Usage: The Synthes Cranial Flap Tube Clamp System is intended to reattach a cranial bone flap to the surrounding cranium after a craniotomy procedure.
- Manufacturer
- Synthes (USA) Products LLC
- Hazard
- Affected units
- 105,882
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)
- 4154144
- 4206682
- 4206683
- 4213557
- 4214824
- 4216603
- 4216604
- 4240689
- 4240690
- 4241741
- 4248462
- 4249395
- 4249396
- 4264386
- 4278302
- 4278304
- 4283035
- 4283036
- 4283037
- 4283038
Distribution
Distributed nationwide across the United States.
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