BioHorizons Canada Medical Devices (2020-09-30)
- Starting date:
- September 30, 2020
- Posting date:
- October 30, 2020
- 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-74219
Last updated: 2020-10-30
Affected Products
A. Astra OsseospeedInterface non-engaging NP 3.
B. Nobel ActiveTi Base non engaging Active 3.0
C. Nobel ActiveTi Base non engaging Active WP
D. ConelogTi Base non engaging 3.3
E. ConelogTi Base non engaging 3.8 / 4.3
F. ConelogTi Base non engaging 5.0
G. BioHorizons (int)Ti Base non engaging 3.5 (Bio Horizons Int)
H. BioHorizons (int)Ti Base non engaging 4.5 (Bio Horizons Int)
I. BioHorizons (int)Ti Base non engaging 5.7 (Bio Horizons Int)
J. Astra OsseospeedInterface engaging NP
K. Nobel ActiveInterface engaging 3.0
L. Nobel ActiveInterface engaging WP
M. Straumann Tissue LevelInterface engaging NNC 3.3
N. ConelogInterface engaging 3.3 Conelog
O. ConelogInterface engaging 3.8 / 4.3 Conelog
P. ConelogInterface engaging 5.0 Conelog
Q. MIS C1 / V3Interface engaging C1 / V3 SP
R. BioHorizons (int)Interface engaging 3.5
S. BioHorizons (int)Interface engaging 4.5
T. BioHorizons (int)Interface engaging 5.7
U. Nobel ReplaceInterface engaging 6.0
V. CamlogTemporary Abutment 3.8 non engaging
W. CamlogTemporary Abutment 4.3 non engaging
X. Camlog ANGLEBase 3.8 non engaging
Y. Camlog ANGLEBase 4.3 non engaging
Z. Camlog ANGLEBase 3.8 engaging
AA. Camlog ANGLEBase 4.3 engaging
Reason
Class III medical devices not licensed by Health Canada were imported and distributed in Canada by BioHorizons Canada. The import and distribution of affected devices was the result of a failure to follow documented procedures that ensure only licensed devices are set up for purchase by BioHorizons Canada.
Affected products
A. Astra OsseospeedInterface non-engaging NP 3.
Lot or serial number
13946
Model or catalog number
DES-15.023
Companies
- Manufacturer
-
Terrats Medical S.L.
Calle Mogoda 75-99, Barbera de Valles
Barcelona
8210
SPAIN
B. Nobel ActiveTi Base non engaging Active 3.0
Lot or serial number
11994
Model or catalog number
DES-15.068
Companies
- Manufacturer
-
Terrats Medical S.L.
Calle Mogoda 75-99, Barbera de Valles
Barcelona
8210
SPAIN
C. Nobel ActiveTi Base non engaging Active WP
Lot or serial number
12897
15065
Model or catalog number
DES-15.069
Companies
- Manufacturer
-
Terrats Medical S.L.
Calle Mogoda 75-99, Barbera de Valles
Barcelona
8210
SPAIN
D. ConelogTi Base non engaging 3.3
Lot or serial number
13038
Model or catalog number
DES-15.074
Companies
- Manufacturer
-
Terrats Medical S.L.
Calle Mogoda 75-99, Barbera de Valles
Barcelona
8210
SPAIN
E. ConelogTi Base non engaging 3.8 / 4.3
Lot or serial number
13725
Model or catalog number
DES-15.075
Companies
- Manufacturer
-
Terrats Medical S.L.
Calle Mogoda 75-99, Barbera de Valles
Barcelona
8210
SPAIN
F. ConelogTi Base non engaging 5.0
Lot or serial number
13724
Model or catalog number
DES-15.076
Companies
- Manufacturer
-
Terrats Medical S.L.
Calle Mogoda 75-99, Barbera de Valles
Barcelona
8210
SPAIN
G. BioHorizons (int)Ti Base non engaging 3.5 (Bio Horizons Int)
Lot or serial number
15066
Model or catalog number
DES-15.087
Companies
- Manufacturer
-
Terrats Medical S.L.
Calle Mogoda 75-99, Barbera de Valles
Barcelona
8210
SPAIN
H. BioHorizons (int)Ti Base non engaging 4.5 (Bio Horizons Int)
Lot or serial number
15067
Model or catalog number
DES-15.088
Companies
- Manufacturer
-
Terrats Medical S.L.
Calle Mogoda 75-99, Barbera de Valles
Barcelona
8210
SPAIN
I. BioHorizons (int)Ti Base non engaging 5.7 (Bio Horizons Int)
Lot or serial number
13722
Model or catalog number
DES-15.089
Companies
- Manufacturer
-
Terrats Medical S.L.
Calle Mogoda 75-99, Barbera de Valles
Barcelona
8210
SPAIN
J. Astra OsseospeedInterface engaging NP
Lot or serial number
12593
Model or catalog number
DES-16.023
Companies
- Manufacturer
-
Terrats Medical S.L.
Calle Mogoda 75-99, Barbera de Valles
Barcelona
8210
SPAIN
K. Nobel ActiveInterface engaging 3.0
Lot or serial number
15278
Model or catalog number
DES-16.068
Companies
- Manufacturer
-
Terrats Medical S.L.
Calle Mogoda 75-99, Barbera de Valles
Barcelona
8210
SPAIN
L. Nobel ActiveInterface engaging WP
Lot or serial number
17187
Model or catalog number
DES-16.069
Companies
- Manufacturer
-
Terrats Medical S.L.
Calle Mogoda 75-99, Barbera de Valles
Barcelona
8210
SPAIN
M. Straumann Tissue LevelInterface engaging NNC 3.3
Lot or serial number
12413
Model or catalog number
DES-16.070
Companies
- Manufacturer
-
Terrats Medical S.L.
Calle Mogoda 75-99, Barbera de Valles
Barcelona
8210
SPAIN
N. ConelogInterface engaging 3.3 Conelog
Lot or serial number
12769
Model or catalog number
DES-16.074
Companies
- Manufacturer
-
Terrats Medical S.L.
Calle Mogoda 75-99, Barbera de Valles
Barcelona
8210
SPAIN
O. ConelogInterface engaging 3.8 / 4.3 Conelog
Lot or serial number
15200
Model or catalog number
DES-16.075
Companies
- Manufacturer
-
Terrats Medical S.L.
Calle Mogoda 75-99, Barbera de Valles
Barcelona
8210
SPAIN
P. ConelogInterface engaging 5.0 Conelog
Lot or serial number
12898
Model or catalog number
DES-16.076
Companies
- Manufacturer
-
Terrats Medical S.L.
Calle Mogoda 75-99, Barbera de Valles
Barcelona
8210
SPAIN
Q. MIS C1 / V3Interface engaging C1 / V3 SP
Lot or serial number
12208
Model or catalog number
DES-16.082
Companies
- Manufacturer
-
Terrats Medical S.L.
Calle Mogoda 75-99, Barbera de Valles
Barcelona
8210
SPAIN
R. BioHorizons (int)Interface engaging 3.5
Lot or serial number
17194
Model or catalog number
DES-16.087
Companies
- Manufacturer
-
Terrats Medical S.L.
Calle Mogoda 75-99, Barbera de Valles
Barcelona
8210
SPAIN
S. BioHorizons (int)Interface engaging 4.5
Lot or serial number
16561
Model or catalog number
DES-16.088
Companies
- Manufacturer
-
Terrats Medical S.L.
Calle Mogoda 75-99, Barbera de Valles
Barcelona
8210
SPAIN
T. BioHorizons (int)Interface engaging 5.7
Lot or serial number
15433
Model or catalog number
DES-16.089
Companies
- Manufacturer
-
Terrats Medical S.L.
Calle Mogoda 75-99, Barbera de Valles
Barcelona
8210
SPAIN
U. Nobel ReplaceInterface engaging 6.0
Lot or serial number
16530
Model or catalog number
DES-16.097
Companies
- Manufacturer
-
Terrats Medical S.L.
Calle Mogoda 75-99, Barbera de Valles
Barcelona
8210
SPAIN
V. CamlogTemporary Abutment 3.8 non engaging
Lot or serial number
12176
Model or catalog number
DES-24.065
Companies
- Manufacturer
-
Terrats Medical S.L.
Calle Mogoda 75-99, Barbera de Valles
Barcelona
8210
SPAIN
W. CamlogTemporary Abutment 4.3 non engaging
Lot or serial number
12175
Model or catalog number
DES-24.066
Companies
- Manufacturer
-
Terrats Medical S.L.
Calle Mogoda 75-99, Barbera de Valles
Barcelona
8210
SPAIN
X. Camlog ANGLEBase 3.8 non engaging
Lot or serial number
17393
Model or catalog number
DES-36.065
Companies
- Manufacturer
-
Terrats Medical S.L.
Calle Mogoda 75-99, Barbera de Valles
Barcelona
8210
SPAIN
Y. Camlog ANGLEBase 4.3 non engaging
Lot or serial number
17068
Model or catalog number
DES-36.066
Companies
- Manufacturer
-
Terrats Medical S.L.
Calle Mogoda 75-99, Barbera de Valles
Barcelona
8210
SPAIN
Z. Camlog ANGLEBase 3.8 engaging
Lot or serial number
16877
Model or catalog number
DES-37.065
Companies
- Manufacturer
-
Terrats Medical S.L.
Calle Mogoda 75-99, Barbera de Valles
Barcelona
8210
SPAIN
AA. Camlog ANGLEBase 4.3 engaging
Lot or serial number
10619
17427
Model or catalog number
DES-37.066
Companies
- Manufacturer
-
Terrats Medical S.L.
Calle Mogoda 75-99, Barbera de Valles
Barcelona
8210
SPAIN