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Full Osseotite Implant
- Starting date:
- September 28, 2012
- Posting date:
- November 26, 2012
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public (GP), Healthcare Professionals, Hospitals
- Identification number:
- RA-15891
Recalled Products
- Full Osseotite 2 Tapered Certain Implant
- Full Osseotite Parallel Walled Certain Implant
Reason
A small number of implants from the above referenced lot number may contain a manufacturing condition where the depth of the implant's internal hex is too shallow. The condition, if present, may prevent the driver or abutment from fully engaging the implant.
Affected products
A. Full Osseotite 2 Tapered Certain Implant
Lot or serial number
Not available
Model or catalog number
FNT413
Companies
- Manufacturer
- BioMet 3I, also trading as Implant Innovations Inc.
B. Full Osseotite Parallel Walled Certain Implant
Lot or serial number
Not Available
Model or catalog number
FOS411
Companies
- Manufacturer
- BioMet 3I, also trading as Implant Innovations Inc.