Events

Recall of Device Recall ANSPACH Electric System Foot Control with Direction Only

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
    63086
  • Event Risk Class
    Class 2
  • Event Number
    Z-0075-2013
  • Event Initiated Date
    2012-01-09
  • Event Date Posted
    2012-10-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-09-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=113406
  • 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 the foot control/foot pedal due to the foot control cable lacking the shield connection from the cable to the connector body.
  • Action
    Anspach sent an Urgent Product Removal letter dated January 9, 2012 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to contact their sales representative to facilitate the removal action by providing a replacement for the affected product. For question contact your local sales representative or the Product Support department.

Device

Device Recall ANSPACH Electric System Foot Control with Direction Only
  • Model / Serial
    Serial Numbers: E28305271001, E28305271002, E28305271003, E28305271004, E2830527100, E28305271006, E28305271007, E28305271008, E2830521009, E28305271010, E29305270901, E29305270902, E29305270903, E29305271101, E29305271102, E29305271103, E29305271104, E29305271105, E29305271106, E29305271107, E29.
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US (nationwide) and the countries of: Italy, Japan, Switzerland, Turkey and Taiwan.
  • Product Description
    "***Electric Systems Foot Control with Direction Only***Rx Only***" || Product Usage: || Cutting and shaping bone including bones of the spine and cranium.
  • 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