Events

Recall of Anspach Cutters and Attachments

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
    67124
  • Event Risk Class
    Class 2
  • Event Number
    Z-0708-2014
  • Event Initiated Date
    2012-10-26
  • Event Date Posted
    2014-01-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-06-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124743
  • 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
    During a recent review of documentation anspach determined that the current directions for use for the mca cutting burrs and mca micro curved attachment do not provide clear details regarding the intended use specifically for the mca burrs. the mca burrs are intended for use in delicate bone in otologic procedures such as cochleostomy. the use of the device in dense bone removal may result in cu.
  • Action
    Anspach sent an Urgent Medical Removal letter dated October 26, 2012, to all affected customers. The letter stated that they were initiating a Medical Device removal regarding the MCA Cutting Burrs. During a recent review of documentation it was determined that the current directions for use for the MCA cutting burrs (item 18-0079) and MCA Micro Curved Attachment (item 18-0060) did not provide clear details regarding the intended use specifically for the MCA burrs. The MCA burrs are intended for use in delicate bone in otologic procedures such as cochleostomy. The use of the device in dense bone removal may result in cutter/ burr fracture. If a fracture occurs, contact Customer Support at (800) 327-6887 or email ProductSupportTeam@synthes.com. If the procedure was done successfully, no additional patient follow up is necessary. Customer Immediate Actions: 1. Please remove and return any MCA items from your inventory immediately. 2. Complete the attached reply form indicating your receipt of this letter. Return the completed form by fax or email to the number or email address provided on the form. If you distribute any of the products to other services or facilities, please forward this information as appropriate. Customers with questions were instructed to contact Anspach Customer Support at (800) 327-6887 or email ProductSupportTeam@synthes.com. For questions regarding this recall call 1-800-327-6887.

Device

Anspach Cutters and Attachments
  • Model / Serial
    All Lots for  MCA - MICRO CURVED ATTACHMENT,  MCA5-05SD - 0.5MM DIAMOND BALL, 5.6CM,  MCA5-06SD - 0.6MM DIAMOND BALL, 5.6CM,  MCA5-07SD - 0.7MM DIAMOND BALL, 5.6CM,  MCA5-08SD - 0.8MM DIAMOND BALL, 5.6CM,  MCA5-15SB - 1.5MM FLUTED BALL, 5.6CM,  MCA5-15SD - 1.5MM DIAMOND BALL, 5.6CM,  MCA5-1SB - lMM FLUTED BALL, 5.6CM,  MCA5-1SD - lMM DIAMOND BALL, 5.6CM,  MCA5-2SB - 2MM FLUTED BALL, 5.6CM,  MCA5-2SD - 2MM DIAMOND BALL, 5.6CM,  MCA7-05SD - 0.5MM DIAMOND BALL, 7.3CM,  MCA7-06SD - 0.6MM DIAMOND BALL, 7 .3CM,  MCA7-07SD - 0.7MM DIAMOND BALL, 7.3CM,  MCA7-08SD - 0.8MM DIAMOND BALL, 7.3CM,  MCA7-15SB - 1.5MM FLUTED BALL, 7.3CM,  MCA7-15SD  1.5MM DIAMOND BALL, 7.3CM,  MCA7-1SB - lMM FLUTED BALL, 7.3CM,  MCA7-1SD - 1 MM DIAMOND BALL, 7 .3CM,  MCA7-2SB - 2MM FLUTED BALL, 7.3CM and  MCA7-2SD - 2MM DIAMOND BALL, 7.3CM.
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and Internationally to Canada, Netherlands, Great Britain, France, Sweeden, Italy, Spain, Japan, South Africa, Australia, Switzerland,
  • Product Description
    Multiples Anspach Micro Curved Attachments (MCA) and Curved Burr Support S leves (Cutters and Attachments) || MCA - MICRO CURVED ATTACHMENT, || MCA5-05SD - 0.5MM DIAMOND BALL, 5.6CM, || MCA5-06SD - 0.6MM DIAMOND BALL, 5.6CM, || MCA5-07SD - 0.7MM DIAMOND BALL, 5.6CM, || MCA5-08SD - 0.8MM DIAMOND BALL, 5.6CM, || MCA5-15SB - 1.5MM FLUTED BALL, 5.6CM, || MCA5-15SD - 1.5MM DIAMOND BALL, 5.6CM, || MCA5-1SB - lMM FLUTED BALL, 5.6CM, || MCA5-1SD - lMM DIAMOND BALL, 5.6CM, || MCA5-2SB - 2MM FLUTED BALL, 5.6CM, || MCA5-2SD - 2MM DIAMOND BALL, 5.6CM, || MCA7-05SD - 0.5MM DIAMOND BALL, 7.3CM, || MCA7-06SD - 0.6MM DIAMOND BALL, 7 .3CM, || MCA7-07SD - 0.7MM DIAMOND BALL, 7.3CM, || MCA7-08SD - 0.8MM DIAMOND BALL, 7.3CM, || MCA7-15SB - 1.5MM FLUTED BALL, 7.3CM, || MCA7-15SD  1.5MM DIAMOND BALL, 7.3CM, || MCA7-1SB - lMM FLUTED BALL, 7.3CM, || MCA7-1SD - 1 MM DIAMOND BALL, 7 .3CM, || MCA7-2SB - 2MM FLUTED BALL, 7.3CM and || MCA7-2SD - 2MM DIAMOND BALL, 7.3CM. || The MCA attachment is a reusable device used with dissection tools. Dissection tools are single use, disposable cutter designed for cutting and shaping delicate bone, primary in otology procedures for delicate bone cutting.
  • 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