Device product
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.
Z-1788-2014
Product summary
- Firm
- Kerr Corporation
- Event
- Event 68426
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2,030 units
- Official record key
device-enforcement:Z-1788-2014
Official wording
Reason: 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.
Code information: Part Number 29948, Lot Number 3-1294. Expires October 2016
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.
Derived failure modes
-
Unknown
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.