FDAFDA · Food and drugs·Recall number Z-1788-2014
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.
Published June 25, 2014 · Recall initiated: May 29, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Kerr Corporation
- Distributor
- 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.
- Lot
- Part Number 29948, Lot Number 3-1294. Expires October 2016
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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