Events

Recall of Device Recall Anspach Custom MCA51SD with Extended Exposure

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
    64247
  • Event Risk Class
    Class 2
  • Event Number
    Z-1879-2014
  • Event Initiated Date
    2012-11-28
  • Event Date Posted
    2014-06-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-08-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115697
  • 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
    Drills, burrs, trephines & accessories (simple, powered) - Product Code HBE
  • Reason
    The anspach effort, inc. in palm beach gardens, fl is recalling their anspach custom devices. the units were not manufactured consistently with quality system requirements.
  • Action
    The Anspach Effort, Inc. sent an Urgent Medical Device Recall letter dated December 21, 2012 to all affected customers. The letter identified the affected products, problems and actions to be taken. Customers were instructed to remove and return the affected products and complete the attached reply form and return to The Anspach Effort Inc. For questions contact Anspach Product Support at (800) 327-6887. For questions regarding this recall call 561-494-3706.

Device

Device Recall Anspach Custom MCA51SD with Extended Exposure
  • Model / Serial
    Part Numbers: 98-0049, 98-0051; Serial Numbers: 2000729, 2000761
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA including AL, CA, FL, IA, IL, KY, MN, MS, NC, OH, OK, PA, TN, TX.and Internationally to Canada, Japan, Hungary, Korea and Sweden. .
  • Product Description
    ANSPACH***Custom MCA5-1SD with Extended Exposure***Rx Only*** || This device is intended to be used with Anspach Systems
  • 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