Events

Recall of BURR - FLUTED BALL

According to Health Canada (via FOI), this recall involved a device in Canada 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
    24238
  • Event Risk Class
    II
  • Event Initiated Date
    2013-01-10
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    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 use of the device in dense bone removal may result in cutter fracture.

Device

BURR - FLUTED BALL
  • Model / Serial
    Model Catalog: MCA7-15SB (Lot serial: ALL LOTS); Model Catalog: MCA5-2SB (Lot serial: ALL LOTS); Model Catalog: MCA5-1SB (Lot serial: ALL LOTS); Model Catalog: MCA_AO (Lot serial: ALL LOTS); Model Catalog: MCA (Lot serial: ALL LOTS); Model Catalog: MCA7-1SB (Lot serial: ALL LOTS); Model Catalog: MCA7-2SB (Lot serial: ALL LOTS); Model Catalog: MCA5-15SB (Lot serial: ALL LOTS); Model Catalog: MCA5-08SD (Lot serial: ALL LOTS); Model Catalog: MCA5-15SD (Lot serial: ALL LOTS); Model Catalog: MCA5-1SD (Lot serial: ALL LOTS); Model Catalog: MCA5-2SD (Lot serial: ALL LOTS); Model Catalog: MCA7-05SD (Lot serial: ALL LOTS); Model Catalog: MCA7-06SD (Lot serial: ALL LOTS); Model Catalog: MCA7-07SD (Lot serial: ALL LOTS); Model Catalog: MCA7-08SD (Lot serial: ALL LOTS); Model Catalog: MCA7-15SD (Lot serial: ALL LOTS); Model Catalog: MCA7-1SD (Lot serial: ALL LOTS); Model Catalog: MCA5-05SD (Lot serial: ALL LOTS); Model Catalog: MCA5-06SD (Lot serial: ALL LOTS); Model Catalog: MCA5-07SD (Lot serial: ALL LOTS); Model Cata
  • Product Description
    CUTTING BURRS - FLUTED BALL
  • Manufacturer
    THE ANSPACH EFFORT INC.

Manufacturer

THE ANSPACH EFFORT INC.
  • Manufacturer Address
    PALM BEACH GARDENS
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Source
    HC