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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
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
A) Mandible External Fixator System - Adjustable Clamp
Lot or serial number
All lots.
Model or catalog number
03.305.006
03.305.105
Companies
- Manufacturer
-
Synthes (Canada) Ltd.
2566 Meadowpine Blvd.
Mississauga
L5N 6P9
Ontario
CANADA
B) Mandible external fixator system - Schanz Screw
Lot or serial number
All lots.
Model or catalog number
04.305.003
04.305.004
04.305.005
04.305.010
04.305.011
04.305.012
04.305.128
04.305.130
04.305.134
04.305.138
04.305.140
04.305.142
Companies
- Manufacturer
-
Synthes (Canada) Ltd.
2566 Meadowpine Blvd.
Mississauga
L5N 6P9
Ontario
CANADA
C) Mandible external fixator system - Mandible Rod
Lot or serial number
All lots.
Model or catalog number
04.305.100
04.305.101
04.305.102
04.305.103
Companies
- Manufacturer
-
Synthes (Canada) Ltd.
2566 Meadowpine Blvd.
Mississauga
L5N 6P9
Ontario
CANADA