Various Devices of Mandible External Fixator System (2014-10-09)

Starting date:

October 9, 2014

Posting date:

November 7, 2014

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-42065

• 
  Reason
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  Affected products

Recalled Products

A) Mandible External Fixator System - Adjustable Clamp

B) Mandible external fixator system - Schanz Screw

C) Mandible external fixator system - Mandible Rod

Reason

Certain components within the CMF Mandible External Fixator System have been labelled and/or etched with information indicating they are "MR safe". Changes have been made to testing standards (ASTM  F2503) to designate a product safe and compatible in the MR environment.  Per current ASTM  F2503 testing standards, metal devices are not to be identified as MR safe.

Affected products