Kerr Recalls Tytin Dental Restorative Material Due to Fast Setting
Kerr Corporation is recalling one lot of Tytin Regular Set dental restorative material because it may set faster than specified in the Directions for Use.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a deviation from specified performance (setting faster than directed) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Kerr Corporation is recalling one lot of Tytin Regular Set, Double Spill, 50 Capsules (Part Number 29948, Lot Number 3-1294). The device is a dental restorative material intended for the treatment of dental caries.
The recall was initiated because the product may set faster than specified in the Directions for Use. The affected lot expires in October 2016.
The product was distributed worldwide, including the United States (nationwide), Canada, Mexico, Australia, Belgium, Czech Republic, Germany, Spain, France, Great Britain, French Guiana, Italy, Portugal, and Saudi Arabia. A total of 2,030 units were distributed. Consumers and healthcare providers should stop using the affected lot and contact Kerr Corporation for further instructions.
The recalled product
- 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.
- Manufacturer
- Kerr Corporation
- Hazard
- Affected units
- 2,030
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Part Number 29948
- Lot Number 3-1294. Expires October 2016
Distribution
Distributed nationwide across the United States.
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