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Synthes (USA) Products LLC recalls Synthes Cranial Flap Tube Clamp and Crimping Device Product Usage: The Synthes Cranial Flap Tube Clamp System is in
Recalled September 30, 2015 · FDA recall Z-2811-2015 · Synthes (USA) Products
Hazard
The Synthes Cranial Flap Tube Clamp and Crimping Device for Cranial Tube Clamp had been labeled MR Safe although they do not have the testing protocols currently required to designate them as MR Safe. · FDA Class II
Units
105882
Sold at
US Nationwide and internationally, including Canada.
Description
The Synthes Cranial Flap Tube Clamp and Crimping Device for Cranial Tube Clamp had been labeled MR Safe although they do not have the testing protocols currently required to designate them as MR Safe.
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(s)
Synthes (USA) Products LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →