Events

Recall of Foot Pedal

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
    53073
  • Event Risk Class
    Class 2
  • Event Number
    Z-0083-2010
  • Event Initiated Date
    2009-08-13
  • Event Date Posted
    2009-10-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-01-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=84580
  • 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. is recalling the foot control/ foot pedal for sc2000 and sc2100 powered, simple cranial drills, burrs, trephines, and accessories. the foot control cables lacks the shield connection from the cable to the connector body. the lack of shielding may result in radiated emissions which could possibly cause interference on other electrical equipment adjacent to the foot pedal.
  • Action
    Anspach issued an "Urgent Product Removal" Letter dated August 17, 2009 informing customers of the affected product. Consignees are asked to screen their inventory and return any affected product including a completed Product Replacement Form to the firm. For further questions, contact Anspach at 1-800-327-6887 or 1-561-627-1080.

Device

Foot Pedal
  • Model / Serial
    EMAX2-FP Serial Numbers: C26302250301, C26302250302, C26302250303, C26302250304, 5044044307, 31495607, 32380602, 31832209, 31832202 and 32366805; and  EPLUS-FP Serial Numbers: C26302200804 , C26302200802, C27302221701 and C08301701901.
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- Canada, Indonesia, United Kingdom, Korea and United States (NC, OK, TN, CA, KS, MI and WA).
  • Product Description
    Foot Pedal, Foot Control for SC2000 and SC2100 Powered, simple cranial drills, burrs, trephines, and their accessories. Catalog Numbers: EMAX2-FP and FPLUS-FP. || Indicated to cut and shape 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