Events

Recall of Device Recall Anspach cutting burrs

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
    37977
  • Event Risk Class
    Class 2
  • Event Number
    Z-1008-2007
  • Event Initiated Date
    2007-05-18
  • Event Date Posted
    2007-07-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-01-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=52562
  • 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
    Cutting Burrs - Product Code HBB
  • Reason
    The white film portion of the sterile pouch may become brittle prior to the expiry date compromising the sterility of the product.
  • Action
    The firm issued a recall letter on May 18, 2007, to its consignee, advising them of the recall. Consignees were asked to screen their inventory for the recalled devices and complete an accompanying product replacement form. The firm will replace all returned product within 30 days.

Device

Device Recall Anspach cutting burrs
  • Model / Serial
    All cutting burrs packaged with an expiration date between June 2008 and august 2011.
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    World wide-Distributed throughout the United States and to Puerto Rico, Canada, Mexico, Japan, Lithuania, Cyprus, Austrailia, England, Sweden, Bahamas, Korea, Germany, Switzerland, Malaysia, Iceland, Portugal, Singapore, Poland, Hungary, Thailand, Austria, Israel, Belgium, Egypt, South Africa, Netherlands, India, Syria, Kenya, Italy, Czech Republic, Jamaica, Columbia, Argentina, Honduras, Saudi Arabia, Greece, Finland, Taiwan, Republic of China, Lebanon, Denmark, France, Hong Kong, Philippines, Venezuela, Argintina, and the United Kingdom.
  • Product Description
    Anspach Single Use, Sterile Bone Cutting Burrs
  • 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