| ||Class 2 Recall|
||November 08, 2012
||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 Part Numbers Lot Number
AlgiNot Intra Kit 34683 1-1017
AlgiNot Volume Refills 34682 1-1017
28200 Wick Rd
Romulus, Michigan 48174-2639
|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.
||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
||Worldwide Distribution-USA (nationwide) and the countries of Canada, Europe, and Australia.