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Health product recall

CMF Distraction System - AB and BC Craniofacial Distractor Bodies (2014-04-16)

Starting date:
April 16, 2014
Posting date:
April 30, 2014
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type I
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-39277

Recalled Products

  1. CMF Distraction System - AB Craniofacial Distractor Body
  2. CMF Distraction System - BC Craniofacial Distractor Body

Reason

The AB and BC distractor bodies used in the craniomaxillofacial distraction system may reverse post-operatively.

Affected products

A. CMF Distraction System - AB Craniofacial Distractor Body

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number
  • 04.315.003
  • 04.315.004
  • 04.315.005
  • 04.315.006
  • 04.315.053
  • 04.315.054
  • 04.315.055
  • 04.315.056
Companies
Manufacturer
Synthes (Canada) Ltd.
2566 Meadowpine Blvd.
Mississauga
L5N 6P9
Ontario
CANADA

B. CMF Distraction System - BC Craniofacial Distractor Body

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

More than 10 numbers, contact manufacturer.

Companies
Manufacturer
Synthes (Canada) Ltd.
2566 Meadowpine Blvd.
Mississauga
L5N 6P9
Ontario
CANADA