Ceramir Crown and Bridge QuickCap (2019-11-07)

Starting date:

November 7, 2019

Posting date:

November 29, 2019

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-71744

Last updated: 2020-01-06

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  Reason
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  Affected products

Affected Products

Ceramir Crown and Bridge QuickCap

Reason

The recall is performed since the affected products are labelled with the wrong expiry date. The products are labelled with an expiry date of 24 months from manufacturing that should be 18 months. This means that certain capsules in some product Lot's may not fulfill all stated performance parameters for the full 24 months period, even if stored correctly.

The following may happen when using affected capsules:

After mixing the cement thickens faster than usual giving a shorter than 2-minute working time and in some cases the cement gets thick already inside the capsule. The shorter working time may cause problems to get the crowns seated properly which may cause inconvenience. However, the user's ability to detect the problem before attempting to seat the crown is deemed high since the cement gets considerably thicker than usual.

Affected products