Events

Recall of Device Recall Emax Consoles

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by The Anspach Effort, 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
    64973
  • Event Risk Class
    Class 2
  • Event Number
    Z-1658-2013
  • Event Initiated Date
    2011-06-24
  • Event Date Posted
    2013-07-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-12-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117790
  • 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
    Graft,bypass,coronary artery - Product Code NAV
  • Reason
    The rpm of the motor handpiece may be less than 80,000 rpm.
  • Action
    Anspach Effort sent an "URGENT: Medical Device Correction" letter dated June 24, 2011 to their customers via mail. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete a reply form promptly confirming receipt of their letter and return it by fax to the number provided on the form. If any of the affected products were distributed to other services or facilities, please forward this information as appropriate. For questions contact Anspach Customer Support at 800-327-6887 or email customer.support@synthes.com.

Device

Device Recall Emax Consoles
  • Model / Serial
    SC2100 System Console Emax 2 Plus; SC2101 System Console, Single Port with irrigation; SC2102 System Console, Single Port, without Irrigation;
  • Product Classification
    Cardiovascular Devices
  • Device Class
    HDE
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - USA Nationwide including the states of: AZ, CA, FL, KY, ME, MI, MO, OH, PA, TN, TX , VA, and the countries of: Australia, Egypt, Italy, Japan, Switzerland, Taiwan, and Turkey;
  • Product Description
    ***REF SC2102***eMax 2 Plus Console, Single Port, no Irrigation***SN G16307882402*** || Product Usage: || The eMax console is intended to operate the eMax system which is used for cutting and shaping bone including spine and cranium. The RPM of the Motor Handpiece may be less than 80,000 RPM (approximately 72,000 RPM) in the free running state when using the optional Hand Control. The low Motor Handpiece RPM would only be experienced in the Free running state (Hand Control fully depressed and no load on the cutting bur). This condition would not affect the power output of the Handpiece in the loaded working range (typically 50,000 to 70,000 RPM).
  • Manufacturer
    The Anspach Effort, Inc.

Manufacturer

The Anspach Effort, Inc.
  • Manufacturer Address
    The Anspach Effort, Inc., 4500 Riverside Drive, Palm Beach Gardens FL 33410-4235
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Source
    USFDA