Health product recall

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