Z-1788-2014 Class II Terminated

Recalled by Kerr Corporation — Romulus, MI

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