Events

Recall of Device Recall ArthroCare Knot Pusher

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by ArthroCare Medical Corporation.

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
    67087
  • Event Risk Class
    Class 2
  • Event Number
    Z-0652-2014
  • Event Initiated Date
    2013-12-09
  • Event Date Posted
    2014-01-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-04-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124680
  • 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
    orthopedic manual surgical instrument - Product Code LXH
  • Reason
    A sharp edge on the cannulated tip of the device may damage or cut a suture.
  • Action
    All consignees were provided with written notice via Urgent Recall Notification dated December 9, 2013 with delivery confirmation. In addition, the firm plans on notifying the EU, and the governments of France, Germany, Switzerland, and Spain. The firm will also notify the Swedish government because the firm's EU representative is located in Sweden.

Device

Device Recall ArthroCare Knot Pusher
  • Model / Serial
    Catalog #25-3011, Lot #1049402
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: US (nationwide) including states of: CA, FL, GA, IL, IN, KY, MN, MO, NY, OH, TX, and WI. Internationally to: Canada, France, Germany, Spain, and Switzerland.
  • Product Description
    Arthrocare SPORTS MEDICINE, Knot Pusher, REF 25-3011, LOT #1049402, CON 1, 2013-10, NON-STERILE, Rx only
  • Manufacturer
    ArthroCare Medical Corporation

Manufacturer

ArthroCare Medical Corporation
  • Manufacturer Address
    ArthroCare Medical Corporation, 7000 W William Cannon Dr, Austin TX 78735-8509
  • Manufacturer Parent Company (2017)
    Smith & Nephew plc
  • Source
    USFDA