Events

Recall of Device Recall Suros ATEC Breast Biopsy System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Suros Surgical 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
    37071
  • Event Risk Class
    Class 2
  • Event Number
    Z-0362-2007
  • Event Initiated Date
    2006-12-15
  • Event Date Posted
    2007-01-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-05-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49854
  • 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
    biopsy system - Product Code KNW
  • Reason
    The handpiece package may have an incorrect part number on the inner package. error could result in over-penetration of the biopsy needle.
  • Action
    Consignees were notified by phone beginning on 12/15/06 and by follow-up letter dated 12/19/06.

Device

Device Recall Suros ATEC Breast Biopsy System
  • Model / Serial
    Lot 611018.
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide.
  • Product Description
    Suros ATEC Breast Biopsy System handpiece (9 gauge cannula 12 centimeters in length with a 20 millimeter aperture) for use with the ATEC Breast Biopsy and Excision System, disposable, sterile; Part no. 0912-20.
  • Manufacturer
    Suros Surgical Systems Inc.

Manufacturer

Suros Surgical Systems Inc.
  • Manufacturer Address
    Suros Surgical Systems Inc., 6100 Technology Center Dr, Indianapolis IN 46278-6016
  • Source
    USFDA