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Health product recall

Soft Tissue Gauge - 6 mm (2014-04-17)

Starting date:
April 17, 2014
Posting date:
May 6, 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-39343

Recalled products

  1. Soft Tissue Gauge - 6 mm

Reason

Recall initiated due to manufacturing imperfection in the smooth surface of the metal on the soft tissue gauge which resulted in small visible sharp edges and burrs.

Affected products

A. Soft Tissue Gauge - 6 mm

Lot or serial number
  • COH485876
  • 131008
Model or catalog number
  • 95070
Companies
Manufacturer
Cochlear Bone Anchored Solutions Ab
Konstruktionsvagen 14
Molnlycke
43533
SWEDEN