Events

Recall of Device Recall Surgical Headlight

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
    63512
  • Event Risk Class
    Class 2
  • Event Number
    Z-0402-2013
  • Event Initiated Date
    2011-11-17
  • Event Date Posted
    2012-11-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-11-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114097
  • 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
    Light, surgical headlight - Product Code EBA
  • Reason
    The firm recalled the freedom cordless led headlight because some units were assembled with an incorrect component in the control board electronics that may cause some freedom cordless led headlight units to become warm to the touch; however, no skin damage will occur.
  • Action
    Orascoptic sent an "URGENT: MEDICAL DEVICE RECALL" letter dated November 17, 2011. The letter identified the product, problem, and actions to be taken by the customers. An Acknowledgement Form was included for customers to complete and return to the firm. Contact Orascoptic Customer Care at 608-831-2555 for assistance regarding this notice.

Device

Device Recall Surgical Headlight
  • Model / Serial
    Freedom System, Standard Length, Part Number 910863-1, Serial Numbers 77001000-77003470 and Freedom System, Long Length, Part Number 910863-2, Serial Numbers 77001000-77003470.   Freedom Cordless LED Light System has no expiration date. The affected units were produced and distributed since February 2011.
  • Product Classification
    Dental Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) and the countries of Canada, Australia, and Europe.
  • Product Description
    Freedom Cordless LED Light System. Freedom System, Standard Length, Part Number 910863-1, Serial Numbers 77001000-77003470 and Freedom System, Long Length, Part Number 910863-2, Serial Numbers 77001000-77003470. || Freedom Cordless LED Light System is a Class I Medical Device. The device || listing number this product is E115952. || The intended use of this device is to illuminate oral structures and operating areas.
  • Manufacturer
    Kerr Corporation

Manufacturer

Kerr Corporation
  • Manufacturer Address
    Kerr Corporation, 3225 Deming Way, Middleton WI 53562
  • Manufacturer Parent Company (2017)
    Danaher Corporation
  • Source
    USFDA