Esthetic Abutment CC RP System (2019-08-08)
- Starting date:
- August 8, 2019
- Posting date:
- October 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-71111
Last updated: 2019-10-03
Affected Products
- Esthetic Abutment CC RP 1.5mm
- Temporary Abutment Engaging CC RP
- Temporary Abutment Non-Engaging CC RP
- Snappy Abutment 5.5 CC RP 3mm
- Universal Base CC RP 1.5mm
- Temporary Snap Abut Eng CC RP 1.5mm
Reason
Packages of affected abutment lots may contain an incorrect screw. The screw will tighten, however it cannot be guaranteed that the screw will not loosen. In case the screw loosens the abutment should be re-tightened with the correct screw.
Affected products
A. Esthetic Abutment CC RP 1.5mm
Lot or serial number
13077560
Model or catalog number
36669
Companies
- Manufacturer
-
Nobel Biocare AB
Vastra Hamngatan 1
GOTEBORG
40226
SWEDEN
B. Temporary Abutment Engaging CC RP
Lot or serial number
13077622
Model or catalog number
36664
Companies
- Manufacturer
-
Nobel Biocare AB
Vastra Hamngatan 1
GOTEBORG
40226
SWEDEN
C. Temporary Abutment Non-Engaging CC RP
Lot or serial number
13078005
Model or catalog number
36683
Companies
- Manufacturer
-
Nobel Biocare AB
Vastra Hamngatan 1
GOTEBORG
40226
SWEDEN
D. Snappy Abutment 5.5 CC RP 3mm
Lot or serial number
13077700
Model or catalog number
36683
Companies
- Manufacturer
-
Nobel Biocare AB
Vastra Hamngatan 1
GOTEBORG
40226
SWEDEN
E. Universal Base CC RP 1.5mm
Lot or serial number
13076822
Model or catalog number
38214
Companies
- Manufacturer
-
Nobel Biocare AB
Vastra Hamngatan 1
GOTEBORG
40226
SWEDEN
F. Temporary Snap Abut Eng CC RP 1.5mm
Lot or serial number
13077550
13077551
Model or catalog number
38761
Companies
- Manufacturer
-
Nobel Biocare AB
Vastra Hamngatan 1
GOTEBORG
40226
SWEDEN