Recall Z-0268-2013 ยท ELW Material, Impression
Kerr Corporation
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 Corp
| Date | Nov 8, 2012 (initiated Feb 21, 2012) |
| Status | Terminated |
| Reason | 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 | 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 |
| Quantity | 45 kits and 87 refills |
| Distribution | Worldwide Distribution-USA (nationwide) and the countries of Canada, Europe, and Australia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K050604 | KERR VPS IMPRESSION MATERIAL Sybron Dental Specialties, Inc., Apr 15, 2005 |