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Health product recall

Virtual XD

Starting date:
November 7, 2016
Posting date:
December 13, 2016
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-61384

Reason

Complaints were filed claiming the material failed to set up. After investigation, it was determined that the product set time meets specifications at time of production. However, as the material ages the set time may increase.

Affected products

Virtual XD

Lot or serial number

  • UL2220
  • UL2222
  • UL2393
  • UL2395
  • UL4121

Model or catalog number

  • 646461
  • 646462
  • 646469

Companies

Manufacturer
Ivoclar Vivadent Inc.
175 Pineview Drive
Amherst
14228
New York
UNITED STATES