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

Starting date:

September 29, 2015

Posting date:

October 22, 2015

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-55510

• 
  Reason
• 
  Affected products

• A. TI CRANIAL FLAP TUBE CLAMP
• B. TI CRANIAL FLAP TUBE CLAMP - TEXTURED
• C. SUMMIT OCT SPINAL SYSTEM - TRANS CONNECTOR HOOK

Reason

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.

Affected products