FDA-Device2012-11-14Class II
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 Class II Medical Device. The device listing number this product is 0136496 and the establishment registration number for Kerr Corporation is 1815757. Intended as an alternative to traditional alginate materials.
Kerr Corporation
Hazard
The firm recalled the product because it may cure harder than expected within the shelf life, which could result in a material that may be more difficult to remove. Use of this product on patients with loose teeth may result in possible tooth fracture or tooth extraction.
Sold states
Worldwide Distribution-USA (nationwide) and the countries of Canada, Europe, and Australia.
Affected count
45 kits and 87 refills
Manufactured in
28200 Wick Rd, N/A, Romulus, MI, United States
Products
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 Class II Medical Device. The device listing number this product is 0136496 and the establishment registration number for Kerr Corporation is 1815757. Intended as an alternative to traditional alginate materials.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0268-2013Don't want to check this manually?
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