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Silane Refill (2014-11-20)
- Starting date:
- November 20, 2014
- Posting date:
- December 18, 2014
- 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-42957
Recalled Products
Silane Refill
Reason
Instruction for use for Silane lists an incorrect statement in the "indications" section. The indications incorrectly states, "Silane is intended to be used as a coupler between the prepared tooth and the cement on the restoration." the correct indications should state, "Silane is intended to be used as a coupler between the cement and porcelain restoration."
Affected products
Silane Refill
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
N04EA
Companies
- Manufacturer
-
Kerr Corporation
1717 West Collins Ave.
Orange
92867
California
UNITED STATES