Events

Recall of Device Recall Mammotome Revolve Dual Vacuum Assist Biopsy System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Devicor Medical Products 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
    76603
  • Event Risk Class
    Class 2
  • Event Number
    Z-1512-2017
  • Event Initiated Date
    2017-02-28
  • Event Date Posted
    2017-03-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-08-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=153632
  • 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
    Instrument, biopsy - Product Code KNW
  • Reason
    The device did not have revolve stereo probe labeling, no product code indicating the size and length of the probe, no sterilization sticker or lot number.
  • Action
    Devicor sent an Urgent Medical Device Recall letter dated March 10, 2017 to all affected consignees via first class mail. The recall response rate will be tracked and reconciled by consignee's response form, certifications of product inventory, and/or disposal. Consignees were asked to complete and return the enclosed response form as soon as possible. Consignees with any questions were instructed to call Mammotome Customer Service at 1-877-926-2666. For questions regarding this recall call 513-864-9158.

Device

Device Recall Mammotome Revolve Dual Vacuum Assist Biopsy System
  • Model / Serial
    F11621304D1
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US including IA, IL, NY, OH, OK, PA, TN & WV. Internationally to Chile and Brazil
  • Product Description
    Mammotome Revolve Dual Vacuum Assist Biopsy || System || The device is used to sample breast tissue that has been identified as suspicious under imaging guidance
  • Manufacturer
    Devicor Medical Products Inc

Manufacturer

Devicor Medical Products Inc
  • Manufacturer Address
    Devicor Medical Products Inc, 300 E Business Way Fl 5, Cincinnati OH 45241-2384
  • Source
    USFDA