Events

Recall of Device Recall ENDOTINE Forehead

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Coapt Systems, 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
    26449
  • Event Risk Class
    Class 2
  • Event Number
    Z-1002-03
  • Event Initiated Date
    2003-05-23
  • Event Date Posted
    2003-07-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2003-09-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=27704
  • 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
    unknown device name - Product Code ---
  • Reason
    During use, the device has a potential for unacceptable deep hole in the cranium which can cause patient injury.
  • Action
    On 5/19/03, the firm issued letters via overnight express to all its consignees, informing them of the affected devices and providing instructions on the recall.

Device

Device Recall ENDOTINE Forehead
  • Model / Serial
    Lot Numbers: 00045, 00085 and 00092
  • Distribution
    These products were distributed nationally to 107 consignees and internationally to 2 consignees via distributors and directly to physicians and/or medical facilities. The total number of devices distributed subject to the removal by lot numbers: lot 00045: 19 units; lot 00085: 94 units; and lot 00092: 160 units. The recall was appropriately extended to the consumer/user level; i.e., the wholesalers/distributors, physicians and/or medical facilities who received the recalled products. There is no known U. S. Government or Canadian distribution.
  • Product Description
    Drill bits used in ENDOTINE Forehead¿ 3.5 and 3.0, Catalog Number: CFD-010-4203 and CFD-010-4303
  • Manufacturer
    Coapt Systems, Inc.

Manufacturer

Coapt Systems, Inc.
  • Manufacturer Address
    Coapt Systems, Inc., 1820 Embarcadero Rd., Palo Alto CA 94303
  • Source
    USFDA