Z-1788-2014 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- June 25, 2014
- Initiation Date
- May 29, 2014
- Termination Date
- October 27, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,030 units
Product Description
Tytin Regular Set, Double Spill, 50 Capsules, Part Number 29948, Lot Number 3-1294. The intended use of this device is to be used as a dental restorative material in the treatment of dental caries.
Reason for Recall
Kerr Corporation is recalling one (1) lot of Tytin Regular Set ( Part Number 29948, Lot Number 3-1294), because it may set faster than specified in the Directions for Use.
Distribution Pattern
Worldwide Distribution-USA (nationwide) and the countries of Canada, Mexico, Australia, Belgium, Czech Republic, Germany, Spain, France, Great Britain, French Guiana, Italy, Portugal, and Saudi Arabia.
Code Information
Part Number 29948, Lot Number 3-1294. Expires October 2016