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Endowel (2014-02-26)
- Starting date:
- February 26, 2014
- Posting date:
- April 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-38671
Reason
Recall of all lots of product Endowel by manufactuer following the reclassification of device from Class I to Class II medical devices. Device Endowel was not licensed for sale in Canada due to change of class.
Affected products
Endowel
Lot or serial number
All lots
Model or catalog number
20586X
Companies
- Manufacturer
-
Dentalez, Inc.
Stardental Division
1816 Colonial Village Lane
Lancaster
17601
Pennsylvania
UNITED STATES