Recall Z-0268-2013— Kerr Corporation

Name: FDA recall Z-0268-2013
Creator: U.S. Food and Drug Administration
Published: 2012-02-21

Class II · Terminated

Class II FDA medical device recall by Kerr Corporation, initiated 2012-02-21, terminated 2012-11-15. It names one FDA 510(k) clearance: K050604. 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.. 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..

Recalling firm: Kerr Corporation
Classification: Class II
Status: Terminated
Initiated: 2012-02-21
Terminated: 2012-11-15
Firm location: Romulus, MI, United States

510(k) clearances named in this recall

1 on FDA's record

K050604 — KERR VPS IMPRESSION MATERIALSybron Dental Specialties, Inc.·cleared 2005-04-15

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.