SEMADOS IMPLANTOLOGY SYSTEM (2016-05-27)

Starting date:

May 27, 2016

Posting date:

June 24, 2016

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type III

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-59022

• 
  Reason
• 
  Affected products

Affected products

1. SEMADOS IMPLANTOLOGY SYSTEM - DOLDER ATTACHMENT/F
2. SEMADOS IMPLANTOLOGY SYSTEM - BALL ATTACHMENT MINI
3. SEMADOS IMPLANTOLOGY SYSTEM - PRECI-CLIX FEMALE P

Reason

The CE Declaration of Conformity for products from the supplier ALPHADENT NV was declared invalid on April 4th, 2016.  The annulling of the CE Declaration of Conformity of ALPHADENT NV by the notified body Nemko is not linked to any safety problems associated with the medical devices. The annulling is the result of an application submitted by ALPHADENT NV on 13 September 2013 to the notified body to terminate its contract with the notified body. Nemko responded on 4 April 2016 to this application and informed ALPHADENT NV about the annulling of the relevant CE Declaration of Conformity.

Affected products