Atlantis Abutments Titanium and Atlantis Abutment Gold-Shaded Titanium (2019-08-30)
- Starting date:
- August 30, 2019
- Posting date:
- September 20, 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-71013
Last updated: 2019-09-20
Affected Products
- Atlantis Abutments Titanium
- Atlantis Abutment Gold-Shaded Titanium
Reason
Due to a manufacturing failure the affected abutments have been machined with an incorrect cone. This cone is part of the interface of the implant type the abutment is intended be placed on and ensure the secure seat onto the implant.
Affected products
-
Atlantis Abutments Titanium
Lot or serial number
All lots.
Model or catalog number
35502S
Companies
- Manufacturer
-
DENTSPLY CANADA LTD.
161 Vinyl Court
Woodbridge
L4L 4A3
Ontario
CANADA
B. Atlantis Abutment Gold-Shaded Titanium
Lot or serial number
All lots.
Model or catalog number
35503S
Companies
- Manufacturer
-
DENTSPLY CANADA LTD.
161 Vinyl Court
Woodbridge
L4L 4A3
Ontario
CANADA