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U.S. Department of Health and Human Services

Class 2 Device Recall AlgiNot

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 Class 2 Recall
AlgiNot
see related information
Date Posted November 08, 2012
Recall Status1 Terminated on November 15, 2012
Recall Number Z-0268-2013
Recall Event ID 63297
Premarket Notification
510(K) Number
K050604 
Product Classification Material, Impression - Product Code ELW
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.
Code Information ¿Product Part Numbers Lot Number AlgiNot Intra Kit 34683 1-1017 AlgiNot Volume Refills 34682 1-1017
Recalling Firm/
Manufacturer
Kerr Corporation
28200 Wick Rd
Romulus, Michigan 48174-2639
Manufacturer 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.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): 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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = ELW and Original Applicant = SYBRON DENTAL SPECIALTIES, INC.
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