Events

Recall of Device Recall 0.8MM Diamond Ball, 5.6CM

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
    63624
  • Event Risk Class
    Class 2
  • Event Number
    Z-0753-2014
  • Event Initiated Date
    2012-03-29
  • Event Date Posted
    2014-01-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-03-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114432
  • 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 all lots of the anspach micro curved attachment (mca) cutting burrs and dissection tools. the recall was initiated after the indications for use were found to be broader than the validation of the mca cutting burrs and its directions for use did not clearly state the correct intended use of the device. after a labeling correction, anspach effort, inc. decide.
  • Action
    Firm is performing a Medical Device Recall by sending customers a recall letter and requesting the return of Anspach Micro Curved Attachments and Dissection Tools currently on hand.

Device

Device Recall 0.8MM Diamond Ball, 5.6CM
  • Model / Serial
    All lots are included in recall
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: US (nationwide) and Internationally to: AU, BE, CA, CH, ES, FR, GB, IT, JP, NL, SE, and ZA.
  • Product Description
    MCA5-08SD - 0.8MM Diamond Ball, 5.6CM. All lots are included in recall. || Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy.
  • 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