Events

Recall of Kerr Revolution Formula 2 Flowable Light Cure Composite

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Patterson Dental Supply, Inc..

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
    57242
  • Event Risk Class
    Class 2
  • Event Number
    Z-0716-2011
  • Event Initiated Date
    2010-10-15
  • Event Date Posted
    2010-12-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-09-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95649
  • 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
    Tooth Shade Resin Material - Product Code EBF
  • Reason
    Patterson dental is conducting a recall because they have been advised by the manufacturer of revolution formula 2 (kerr corporation) that some syringes and tips marked with the brand name are not manufactured and distributed by kerr and, thus, not authentic product.
  • Action
    Consignees were sent a Patterson Dental "Urgent Device Recall" letter dated October 15, 2010. The letter was addressed to "Valued Customer". The letter described the product and the problem. It also advised the consignees to quarantine and return the product with the specific distribution dates. Consignees were to complete and return the enclosed Recall Return Form along with the affected product. Questions should be directed to Nancy Strand at 651-686-1966 or nancy.strand@pattersondental.com.

Device

Kerr Revolution Formula 2 Flowable Light Cure Composite
  • Model / Serial
    Shade A1 - Patterson Item # 434-4719;Kerr Part # 29493 Shade A2 - Patterson Item # 434-4727; Kerr Part # 29494 Shade A3 - Patterson Item # 434-4735; Kerr Part # 29495 Shade B1 - Patterson Item # 434-4768; Kerr Part # 29498
  • Product Classification
    Dental Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution -- Including DC except VT.
  • Product Description
    SDS Kerr Revolution Formula 2 Flowable Light Cure Composite. Net Wt. 4 g, Contents 4 Syringes (1g) each. This Package Contains 4 - 12 g Syringes A1, 20 - Dispensing tips, 29493. || SDS Kerr Revolution Formula 2 Flowable Light Cure Composite. Net Wt. 4 g, Contents 4 Syringes (1g) each. This Package Contains 4 - 12 g Syringes A2, 20 - Dispensing tips, 29494. || SDS Kerr Revolution Formula 2 Flowable Light Cure Composite. Net Wt. 4 g, Contents 4 Syringes (1g) each. This Package Contains 4 - 12 g Syringes A3, 20 - Dispensing tips, 29495. || SDS Kerr Revolution Formula 2 Flowable Light Cure Composite. Net Wt. 4 g, Contents 4 Syringes (1g) each. This Package Contains 4 - 12 g Syringes B1, 20 - Dispensing tips, 29499. || Revolution is a flowable light cure hybrid resin restorative.
  • Manufacturer
    Patterson Dental Supply, Inc.

Manufacturer

Patterson Dental Supply, Inc.
  • Manufacturer Address
    Patterson Dental Supply, Inc., 1031 Mendota Heights Rd, Saint Paul MN 55120
  • Manufacturer Parent Company (2017)
    Patterson Dental Supply Inc.
  • Source
    USFDA