Events

Recall of Device Recall BD Beaver ArthroLok Pointed Tip 4mm Blade

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Becton Dickinson and Company.

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
    52291
  • Event Risk Class
    Class 2
  • Event Number
    Z-1638-2010
  • Event Initiated Date
    2009-06-12
  • Event Date Posted
    2010-05-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-01-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=82678
  • 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
    Knife, orthopedic - Product Code HTS
  • Reason
    Mislabeled: arthro-lok pointed tip 4mm blade curving right instead of left.
  • Action
    Becton Dickinson issued an "Urgent: Field Safety Notice" beginning June 25, 2009 by telephone and letter fax to remove and discard affected product from their possession. Customer verification responses were requested. For further information, contact Becton Dickinson and Company at 1-781-906-7900.

Device

Device Recall BD Beaver ArthroLok Pointed Tip 4mm Blade
  • Model / Serial
    Lot Number: 7291713, Expiration Date: 2012-10.
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- United States, Japan and Belgium.
  • Product Description
    BD Beaver Arthro-Lok Pointed Tip 4mm Blade, REF 376780. Becton Dickinson and Company, Waltham, MA 02454. || Intended for use in arthroscopic procedures.
  • Manufacturer
    Becton Dickinson and Company

Manufacturer

Becton Dickinson and Company
  • Manufacturer Address
    Becton Dickinson and Company, 411 Waverley Oaks Rd Ste 2229, Waltham MA 02452-8448
  • Source
    USFDA