Events

Recall of Device Recall SCANLAN Premier Jacobson Micro Scissors

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Scanlan International 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
    32790
  • Event Risk Class
    Class 3
  • Event Number
    Z-1534-05
  • Event Initiated Date
    2005-07-27
  • Event Date Posted
    2005-09-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-12-31
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=41664
  • 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
    Implantable Pacemaker Pulse-Generator - Product Code DXY
  • Reason
    Some scissors purchased before may 1, 2005 may not perform properly. they may have a crack in the blade that could break.
  • Action
    Urgent Medical Device Recall letters were sent 07/27/05 to distributors asking them to retrieve affected product from their customers and return it to Scanlan International, Inc., St. Paul, MN. Distributors are asked to complete and return a Return Fax Form by August 4, 2005 to acknowledge receipt of letter.

Device

Device Recall SCANLAN Premier Jacobson Micro Scissors
  • Model / Serial
    Lot numbers: U7A, U7B, U7C, U7D, V7A, V7B, V7C, V7D and W7A. The lot numbers are located on the inside shank of the instrument near the fulcrum. Please note: If there is a ''T'' on the inside shank of one of the spring handles, the instrument is not included in this recall.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    worldwide. Including the United States and countries such as: Austria, Canada, China, Denmark, Finland, Germany, Greece, India, Italy, Japan, Korea, Malaysia, The Netherlands, Switzerland and Taiwan.
  • Product Description
    SCANLAN Premier Jacobson Micro Scissors, Spring Style, round handle, V-neck, 125-degree angled micro fine blades, 6-1/2'', 16.5 cm. Catalog no. 7007-499.
  • Manufacturer
    Scanlan International Inc

Manufacturer

Scanlan International Inc
  • Manufacturer Address
    Scanlan International Inc, One Scanlan Plaza, Saint Paul MN 55107
  • Source
    USFDA