Product Wiki · Recalls · Health Canada — Medical Devices

TI CRANIAL CLAMPS AND SUMMIT OCT SPINAL SYSTEM (2015-09-29) — recall 54546

Health Canada — Medical Devices · Canada · 2015-10-22 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
54546
Date of alert
2015-10-22
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Notice status
Archived by the issuing authority — kept for reference
Reported risk: The Synthes Cranial Flap Tube Clamp and Crimping Device for cranial tube clamp had been labelled Magnetic Resonance (MR) safe and now must be labelled MR conditional. The company does not have the testing protocols currently required to designate them as MR safe.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/ti-cranial-clamps-and-summit-o

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