Events

Recall of Device Recall AlgiNot

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Kerr Corporation.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    63297
  • Event Risk Class
    Class 2
  • Event Number
    Z-0268-2013
  • Event Initiated Date
    2012-02-21
  • Event Date Posted
    2012-11-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-11-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=113454
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Material, impression - Product Code ELW
  • 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.
  • 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.

Device

Device Recall AlgiNot
  • Model / Serial
    ¿Product Part Numbers Lot Number  AlgiNot Intra Kit 34683 1-1017  AlgiNot Volume Refills 34682 1-1017
  • Product Classification
    Dental Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) and the countries of Canada, Europe, and Australia.
  • 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.
  • Manufacturer
    Kerr Corporation

Manufacturer

Kerr Corporation
  • Manufacturer Address
    Kerr Corporation, 28200 Wick Rd, Romulus MI 48174-2639
  • Manufacturer Parent Company (2017)
    Danaher Corporation
  • Source
    USFDA