The brand name of the device is AlgiNot — Class II medical device recall Z-0268-2013
Terminated recall by Kerr Corporation, reported 2012-11-14, distributed nationwide. The firm recalled the product because it may cure harder than expected within the shelf life, which could resu
| Recall number | Z-0268-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Kerr Corporation, Romulus, MI, United States |
| Recall initiated | 2012-02-21 |
| Classified | 2012-11-08 |
| Reported by FDA | 2012-11-14 |
| Terminated | 2012-11-15 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA |
| Reason classes | device malfunction |
| Lot numbers | 1-1017 |
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 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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0268-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.