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NX3 Try-In Gel (2013-09-10)
- Starting date:
- September 10, 2013
- Posting date:
- October 25, 2013
- 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-36397
Recalled products
A. NX3 Try-In Gel
Reason
The NX3 Try-In gel syringes in the affected lot contain a different product material. The material in the affected syringe does not match the shade of the cement as it is labeled. There is a risk that use of the affected material to evaluate shade prior to cementation may result in an unanticipated final restoration color requiring the need to remove and repeat the restoration.
Affected products
A. NX3 Try-In Gel
Lot or serial number
- Autobag lot number: 4584609
- Syringe lot number: 4580333
Model or catalog number
- 33660
Companies
- Manufacturer
-
Kerr Corporation
1717 West Collins Ave.
Orange
92867
California
UNITED STATES