Synthes (USA) Products LLC recalls Synthes Cranial Flap Tube Clamp and Crimping Device Product Usage: The Synthes Cranial Flap Tube Clamp System is intend…

Recall date

August 31, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2811-2015

FDA classification

Class II

Brand / firm

Synthes (USA) Products LLC

Sold / distributed

US Nationwide and internationally, including Canada.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.