SICAT Implant V2.0 (2020-07-14)

Starting date:

July 14, 2020

Posting date:

August 14, 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-73683

Last updated:
2020-08-14

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  Reason
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  Affected products

Affected Products

SICAT Implant V2.0

Reason

SICAT IMPLANT is a standalone software application, i.e. a radiological visualization software for diagnosis and dental implant planning.

We found that implant planning data exported from SICAT IMPLANT are not correct for one specific export format.

The error in the export format might cause dentists to manufacture (or have manufactured) surgical guides which are incorrect.

Using those guides might cause drilling into the jaw to be either not deep enough or to deep.

A dentist might have to stop a surgical procedure, or the drilling when to deep might cause damage to structures within the jaw.

Affected products