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Health product recall

Para Post System Plastic Burnout Post (2014-05-16)

Starting date:
May 16, 2014
Posting date:
June 12, 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-39993

Recalled products

  1. Para Post System Plastic Burnout Post

Reason

Health Canada has recently reclassified the burnout posts as a Class II medical device. With this reclassification, the para post plastic burnout posts are not licensed for sale in Canada.

Affected products

A. Para Post System Plastic Burnout Post

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

All

Companies
Manufacturer
Coltene/Whaledent, Inc.
235 Ascot Parkway
Cuyahoga Falls
44223
Ohio
UNITED STATES