Events

Recall of Sterile Bone Cutting Bur

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
    57933
  • Event Risk Class
    Class 2
  • Event Number
    Z-2036-2011
  • Event Date Posted
    2011-04-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-08-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97849
  • 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
    Burr, orthopedic - Product Code HTT
  • Reason
    Anspach effort, inc. palm beach gardens, fl is recalling their sterile bone cutting burs that was manufactured with incomplete flutes which could cause degraded cutting performance and in some cases not cut at all. anspach has not received any complaints related to this problem.
  • Action
    The firm, Anspach, sent an "URGENT: Medical Device Product Removal" letter dated October 6, 2010, 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 part numbers listed in the letter. Do not include any product received after October 7, 2010. 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 how many of each part number is being returned and confirming 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

Sterile Bone Cutting Bur
  • Model / Serial
    Lot numbers: C523029666, D063031864, D113032937, D113032974, D163033908, D253036524, and D353039102.
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA including states of: AZ, CA, FL, GA, IL, IN, LA, MA, and MI; and countries of: Australia, Belgium, England, France, Italy, Japan, South Africa, Spain and Sweden.
  • Product Description
    ***REF MCA5-2SB*** 2 mm Fluted Ball, 5.6 cm. Use with Micro Curved Attachment (MCA).***ANSPACH***Sterile, Sterilized using Irradiation***Rx Only*** Made in the USA***Manufacturer: The Anspach Effort, Inc. 4500 Riverside Drive, Palm Beach Gardens, FL 33410 USA Tele: (800) 327-6887/ + 1 561 627 1080***Anspach Europe Ltd. Aston Court, Kingsmead Business Park Frederick Place High Wycombe, HP11 1LA United Kingdom Tel: +441494 616126*** || Lot numbers: C523029666, D063031864, D113032937, D113032974, D163033908, D253036524, and D353039102. || Intended 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