Certain BellaTek Titanium Abutment (2019-02-24)
- Starting date:
- February 24, 2019
- Posting date:
- May 3, 2019
- 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-69802
Last updated: 2019-05-03
Affected Products
Certain BellaTek Titanium Abutment
Reason
During manufacturing, it was discovered that component, EDAMI01-Q lot 1218080 (dental abutment) contained a nonconforming condition: The screw stop platform inside the internal diameter of the component had not been manufactured to specification.
Affected products
Certain BellaTek Titanium Abutment
Lot or serial number
6867796-1
Model or catalog number
ILDAT3
Companies
- Manufacturer
-
BIOMET 3i, also trading as Implant Innovations Inc.
4555 Riverside Dr
Palm Beach Gardens
33410
Florida
UNITED STATES