Contact Matrix Plus and Contact Ring Refill (2018-03-09)
- Starting date:
- March 9, 2018
- Posting date:
- April 24, 2018
- 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-66512
Affected products
- Contact Matrix Contact Ring Refill
- Contact Matrix Plus
Reason
In the affected product, the mesial/distal shape of the inward contact rings is potentially incorrect. Specifically, the inward contact rings should have a distal (narrowing) tine shape when placed with the ring oriented toward the front of the mouth. Some contact rings were found to have (widening) tines.
Affected products
-
Contact Matrix Contact Ring Refill
Lot or serial number
- I264R
- L069N
- L06FJ
- L07ZY
- L098P
Model or catalog number
- 88038
Companies
- Manufacturer
-
Danville Materials
2875 Loker Avenue East
Carlsbad
92010
California
UNITED STATES
B. Contact Matrix Plus
Lot or serial number
L03AQ
L04CQ
Model or catalog number
89439
Companies
- Manufacturer
-
Danville Materials
2875 Loker Avenue East
Carlsbad
92010
California
UNITED STATES