Enforcement Report - Week of November 14, 2012
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Product Detail
| Product Description | 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. |
|---|---|
| Recall Number | Z-0268-2013 |
| Classification | Class II |
| Code Info | ÿProduct Part Numbers Lot Number AlgiNot Intra Kit 34683 1-1017 AlgiNot Volume Refills 34682 1-1017 |
| Product Distributed Qty | 45 kits and 87 refills |
| Reason For Recall | 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. |
Event Detail
| Event Id | 63297 |
|---|---|
| Product Type | Devices |
| Status | Completed |
| Recalling Firm | Kerr Corporation |
| City | Romulus |
| State | MI | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-02-21 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Worldwide Distribution-USA (nationwide) and the countries of Canada, Europe, and Australia. |
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