Health product recall

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

  1. Esthetic Abutment CC RP 1.5mm
  2. Temporary Abutment Engaging CC RP
  3. Temporary Abutment Non-Engaging CC RP
  4. Snappy Abutment 5.5 CC RP 3mm
  5. Universal Base CC RP 1.5mm
  6. 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