Events

Recall of Anspach Single Use Sterile Bone Cutting Burs and Irrigation Clips

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
    63071
  • Event Risk Class
    Class 2
  • Event Number
    Z-0718-2014
  • Event Initiated Date
    2011-09-09
  • Event Date Posted
    2014-01-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-04-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=112458
  • 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
    Bit, drill - Product Code HTW
  • Reason
    Recall was initiated due to the observation of separation between clear layers of the pouch during real time aging studies. as a result, it is possible to have a breach in the sterile barrier.
  • Action
    Recalling firm notified direct accounts by letter on 09/09/11. Direct accounts were instructed to screen their inventory immediately for product packaged with the Tyvek Pouch/Tube Configuration, complete the reply form, and return the products to the firm.

Device

Anspach Single Use Sterile Bone Cutting Burs and Irrigation Clips
  • Model / Serial
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of Japan, Canada, Nigeria, Guam, China, Czech Republic, Thialand, Ecuador, Lithuania, Argentina, Turkey, Cayman Island, Jamaica, India, Jordan, Germany, Brazil, Mexico, Israel, Cameroon, Switzerland, South Africa, Greece, Finland, Taiwan, Hong Kong, France, Spain, Cyprus, Australia, United Kingdom, Sweden, Bahama, Korea, Malaysia, Iceland, Portugal, Polan, Austria, Belgium, Egypt, Singapore, Netherland, Arab Emirates, Kenya, Italy, Venezula, Columbia, Dominican Republic, Chile, Panama, Honduras, Costa Rica, Philippines.
  • Product Description
    Anspach Single Use Sterile Bone Cutting Burs and Irrigation Clips. Rx Only
  • Manufacturer
    The Anspach Effort, Inc.

Manufacturer

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