FDA-Device2015-09-30Class II
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.
Synthes (USA) Products LLC
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.
Sold states
US Nationwide and internationally, including Canada.
Affected count
105882
Manufactured in
1301 Goshen Pkwy, N/A, West Chester, PA, United States
Products
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 notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2811-2015Don't want to check this manually?
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