Events

Recall of Device Recall Anspach Carbide 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
    67146
  • Event Risk Class
    Class 2
  • Event Number
    Z-0727-2014
  • Event Initiated Date
    2013-12-17
  • Event Date Posted
    2014-01-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-05-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124774
  • 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
    Some carbide cutting burr fractured during use.
  • Action
    The firm, Anspach, sent an "URGENT: MEDICAL DEVICE REMOVAL" letter dated December 19, 2013 to their costumers. The letter described the product, problem and actions to be taken. The customers were instructed to complete the attached reply form confirming your receipt of this letter and return the completed form by Fax to: 1-800-327-6661 or Email: customer.support@synthes.com. Reference RMA 200059216 when returning any devices. If you distribute(d any of the products to other services or facilities, please forward this information as appropriate . Should you have any queries please do not hesitate to contact Anspach Customer Support at 800-327-6887 or e-mail at customer.support@synthes.com.

Device

Device Recall Anspach Carbide Cutting Burrs
  • Model / Serial
    All Lot numbers distributed within the 5 years expiration date (12/13 thru 10/18)
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: US (Nationwide) including state of Hawaii and Internationally to: Australia, Poland, Canada, South Africa, Israel, and Switzerland.
  • Product Description
    Anspach Carbide Cutting Burrs & Drums: || 2MM Carbide Fluted Ball, Extended part # S-2B-C and 7MM Carbide Fluted Ball part # S-7B-C || Anspach cutting burrs are intended for cutting and shaping bone, including 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