Events

Recall of Device Recall ATEC

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
    35552
  • Event Risk Class
    Class 2
  • Event Number
    Z-1160-06
  • Event Initiated Date
    2006-05-25
  • Event Date Posted
    2006-06-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-03-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=46380
  • 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
    Needle Guide Breast Biopsy and Excision - Product Code KNW
  • Reason
    Lack of assurance of sterility, as package may have a seal defect (improperly sealed primary packaging).
  • Action
    Consignees were notified telephone and letter dated 5/25/06 to stop using the recalled product and to return it to the firm. The recall was extended to an additional lot by phone calls to each customer between Julne 26 and 30, 2006 and by letter dated 6/19/06 and sent between June 28 and July 7, 2006.

Device

Device Recall ATEC
  • Model / Serial
    Needle guide lot numbers 603006, exp. 3/1/2008, and 602013, exp. 2/6/2008.
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide.
  • Product Description
    ATEC Breast Biopsy and Excision System Needle Guide, 9 GA, sterile, in packages of 5, Ref ATEC NG09.
  • 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