Events

Recall of Anspach Single Use, Sterile Bone Cutting Burrs (Model SHD4820DS)

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
    62326
  • Event Risk Class
    Class 2
  • Event Number
    Z-2077-2012
  • Event Initiated Date
    2011-09-19
  • Event Date Posted
    2012-07-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-07-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=110229
  • 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
    Anspach effort, inc. palm beach gardens, fl is recalling their single use sterile bone cutting burrs used with xmax, micromax, micromax plus, emax, emax2 and emax2 plus high speed drill systems. it is possible for the cutter to come apart.
  • Action
    The firm, Anspach, sent an "URGENT: Medical Device Product Removal" letter dated December 15, 2011, to its customers. The letter describes the product, problem and actions to be taken. The customers were instructed to do the following: 1) Screen their inventory immediately for any of the batches listed in the letter. 2) If they have any of the products listed, contact Anspach Customer Support at (800) 327-6887 to arrange for their immediate return and replacement. 3) Complete and return the attached Customer Reply form indicating if the item(s) are being returned and confiming their receipt of this letter, and fax to 1-800-327-6661. If they have distributed 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.

Device

Anspach Single Use, Sterile Bone Cutting Burrs (Model SHD4820DS)
  • Model / Serial
    Lot numbers E203050779 and E383055709.
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution including the states of: Arizona. and California.
  • Product Description
    .***ANSPACH***Sterile. REF SHD-4820DS***QTY: 1, 4.8 mm x 2mm Twist Drill with Depth Stop. Use with SHORT-HD Attachment ***RX Only || Product Usage: || Cutting and shaping 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