Z-0268-2013Class II

The brand name of the device is AlgiNot, a dental impression material. Product Part Numbers AlgiNot Intra Kit...

Name: Z-0268-2013 The brand name of the device is AlgiNot, a dental impression material. Product Part Numbers AlgiNot Intra Kit...
Creator: Kerr Corporation
Published: 2012-02-21
License: https://open.fda.gov/license/

Kerr Corporation / initiated 2012-02-21 / Terminated / root cause: manufacturing process

FDA source

Kerr Corporation began a recall of 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... on 2012-02-21. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0268-2013
Classification: Class II
Status: Terminated
Initiated: 2012-02-21
Posted: 2012-11-08
Terminated: 2012-11-15
Recalling firm: Kerr Corporation
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.
Product code: ELW Material, Impression
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Kerr Corporation sent "URGENT: MEDICAL DEVICE RECALL" letters to all affected customers. The letters identified the product, problem, and actions to be taken by the customers. US, Canadian, and Rest of World consignees were notified via USPS 1st class mail on June 19, 2012, and Australian consignees on July 5, 2012. Consignees were instructed to complete and return the Acknowledgement Form. Notification of the recall expansion was sent, via USPS 1st class mail, on February 21, 2012 to US, Canadian, Australia and European, consignees; however, once further investigation determined that all unexpired lots of the product were affected, the Alginot recall was expanded a second recall letter was sent to clarify that all lots of AlgiNot FS Volume recall and AlgiNot recall expansion are affected by this expanded recall. Letters were mailed to US, Canadian and Rest of World (ROW) customers on June 19, 2012; Australian and European consignees were notified of the expansion on July 5, 2012. All consignees were instructed to complete the Return Form to acknowledge the updated instructions for use and the added cautionary statement. Consignees not responding are to be contacted at least three times via telephone/fax/e-mail as follow up on the recall.
Quantity in commerce: 45 kits and 87 refills
Distribution: Worldwide Distribution-USA (nationwide) and the countries of Canada, Europe, and Australia.
Product codes and lots: ¿Product Part Numbers Lot Number AlgiNot Intra Kit 34683 1-1017 AlgiNot Volume Refills 34682 1-1017

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0268-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0268-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-14	2012-11-08

Product code ELW

K050604Class IIKerr Vps Impression MaterialSybron Dental Specialties, Inc. / cleared 2005-04-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)