Events

Recall of Anspach Single Use, Sterile Bone 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
    58698
  • Event Risk Class
    Class 2
  • Event Number
    Z-2909-2011
  • Event Initiated Date
    2010-10-13
  • Event Date Posted
    2011-08-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-11-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=101660
  • 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
    On july 30th, 2010 the anspach effort, inc. initiated a voluntary recall on their anspach single use, sterile bone cutting burrs. a complaint was recieved stating that the product had failed during a procedure.
  • Action
    The Anspach Effort, Inc. sent an "URGENT: MEDICAL DEVICE PRODUCT REMOVAL" letter dated October 20, 2010 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customer to screen their inventory for the affected product and not to include any product received after October 18, 2010. Customers are instructed to contact Anspach Customer Support at 800-327-6887 to arrange for return and replacement of product. Customers are to complete and return a Customer Reply Form via fax at 800-327-6661. Questions regarding this notice should be directed to Anspach Customer Support at 800-327-6887. Customer notification began on 10/20/2010 in writing (Fed Ex) with instructions to return the required devices. Anspach utilized their sales representatives to facilitate the product replacement and return activities.

Device

Anspach Single Use, Sterile Bone Cutting Burrs
  • Model / Serial
    MCA5-2SD: D163033602, C523029656, and D093032545.  MCA7-2SD: D063031861, D243033598, and D133033340.  MCA5-05SD: D123033186, and D273036958.  MCA7-05SD: D203033309.
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) and the countries of Australia, Belgium, France, Italy, Japan, South Africa, Spain, Sweden, and United Kingdom.
  • Product Description
    ***REF MCA5-05SD, QTY: 1***0.5 mm Diamond Ball, 5.6 cm. Use with Micro Curved Attachment (MCA).***Sterilized using Irradiation***RX Only***ANSPACH Manufacturer***Made in USA***The Anspach Effort, Inc. 4500 Riverside Drive Palm Beach Gardens, FL 33410, USA Tel: (800) 327 6887 / + 1 561 627 1080***Anspach Europe Ltd. Aston Court, Kingsmead Business Park Frederick Place High Wycombe, HP 11 1LA United Kingdom Tel: +441494 616126*** || ***REF MCA7-05SD, QTY: 1***0.5 mm Diamond Ball, 7.3 cm. Use with Micro Curved Attachment (MCA).***Sterilized using Irradiation***RX Only***ANSPACH Manufacturer***Made in USA***The Anspach Effort, Inc. 4500 Riverside Drive Palm Beach Gardens, FL 33410, USA Tel: (800) 327 6887 / + 1 561 627 1080***Anspach Europe Ltd. Aston Court, Kingsmead Business Park Frederick Place High Wycombe, HP 11 1LA United Kingdom Tel: +441494 616126*** || 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