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ENDOBON XENOGRAFTANULE GRS (2016-01-25)
- Starting date:
- January 25, 2016
- Posting date:
- February 8, 2016
- 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-57018
Affected products
ENDOBON XENOGRAFTANULE GRS
Reason
The cytotoxicity study of Endobon Xenograft Granules revealed severe (grade 4) toxicity after 36 months real-time ageing. This finding was also reported after accelerated ageing equivalent to 36 months real-time.
Affected products
ENDOBON XENOGRAFTANULE GRS
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
- ROX05
- ROX10
- ROX20
- ROXLG20
- ROXLG50
- ROXLG80
Companies
- Manufacturer
-
Biomet France Sarl
VALENCE
FRANCE