Kerr Recalls AlgiNot Dental Impression Material Due to Curing Defect
Kerr Corporation is recalling AlgiNot dental impression material because it may cure harder than expected, potentially causing tooth fractures in patients with loose teeth.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (potential tooth fracture or extraction) where specific injuries have not yet been reported, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Kerr Corporation is voluntarily recalling AlgiNot dental impression material, a Class II medical device intended as an alternative to traditional alginate materials. The recall affects 45 AlgiNot Intra Kits (Part Number 34683) and 87 AlgiNot Volume Refills (Part Number 34682), all from Lot Number 1-1017.
The firm initiated the recall because the material may cure harder than expected within its shelf life. This defect could make the material more difficult to remove from the patient's mouth. Specifically, the use of this product on patients with loose teeth may result in possible tooth fracture or the need for tooth extraction.
The affected products were distributed worldwide, including nationwide in the United States, as well as in Canada, Europe, and Australia. Dental professionals and patients should stop using the affected lot and contact Kerr Corporation for further instructions.
The recalled product
- Product
- The brand name of the device is AlgiNot, a dental impression material. Product Part Numbers AlgiNot Intra Kit 34683 AlgiNot Volume Refills 34682 Lot Number 1-1017 AlgiNot is a C
- Manufacturer
- Kerr Corporation
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Kerr Corporation
See all →- ModerateKerr Recalls Tytin Dental Restorative Material Due to Fast Setting
FDA (Devices) · 2014-06-25
- ModerateKerr Laser Loupes Recalled Due to Wipeable Laser Frequency Markings
FDA (Devices) · 2012-11-28
- HighKerr Recalls BioPlant Dental Bone Grafting Material Due to Ossification Delay
FDA (Devices) · 2012-11-28
- ModerateKerr Recalls Freedom Cordless LED Light System Due to Warmth
FDA (Devices) · 2012-11-28