Events

Recall of Device Recall Apple Medical Corporation

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Apple Medical 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
    34810
  • Event Risk Class
    Class 2
  • Event Number
    Z-0620-06
  • Event Initiated Date
    2006-03-10
  • Event Date Posted
    2006-04-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-03-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=44750
  • 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
    Electrocautery, Gynecologic (And Accessories) - Product Code HGI
  • Reason
    Change in product material may be cause for wire breaking, and tip burning and melting during procedure. broken pieces of the device may need to be retrieved from patient.
  • Action
    Apple Medical Corporation issued letters dated March 21, 2006 to direct accounts and distributors via US Mail. Distributors are requested to sub-recall. Product is to be returned to the firm and destroyed.

Device

Device Recall Apple Medical Corporation
  • Model / Serial
    Lot Numbers:  A2006, D205006
  • Product Classification
    Obstetrical and Gynecological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Foreign: Australia, Austria, Taiwan, England, FInland, Germany, Iceland, Israel, Italy, Portugal, Hong Kong, Spain, The Netherlands, Chile.
  • Product Description
    Fischer Cone Biopsy Excisor || Model: 900-157
  • Manufacturer
    Apple Medical Corporation

Manufacturer

Apple Medical Corporation
  • Manufacturer Address
    Apple Medical Corporation, 28 Lord Rd Ste 135, Marlborough MA 01752-4549
  • Source
    USFDA