FDAFDA · Food and drugs·Recall number Z-0268-2013
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.
Published November 14, 2012 · Recall initiated: February 21, 2012
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
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Kerr Corporation
- Distributor
- Worldwide Distribution-USA (nationwide) and the countries of Canada, Europe, and Australia.
- Lot
- ¿Product Part Numbers Lot Number AlgiNot Intra Kit 34683 1-1017 AlgiNot Volume Refills 34682 1-1017
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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