FDAAugust 31, 2015device
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.
Official recall recorded by the U.S. Food & Drug Administration.
The 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.
What to do
FDA enforcement status: Terminated
Brands named
synthes usa productssynthessynthes usa
Recall history
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