The brand name of the device is AlgiNot, a dental impression material. Product Part Numbers AlgiNot Intra Kit 34683 Algi

FDA device recall Z-0268-2013 · posted 2012-11-08 · Terminated

Recall details

Recalling firm

Kerr Corporation

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.

Action taken

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.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

ELW

Quantity affected

45 kits and 87 refills

Distribution

Worldwide Distribution-USA (nationwide) and the countries of Canada, Europe, and Australia.

Date initiated

2012-02-21

Date posted

2012-11-08

Date terminated

2012-11-15

Location

Romulus, MI

Related 510(k) clearances