Recall of ArthroCare Opus SpeedLock

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by ArthroCare 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
  • Event ID
  • Event Risk Class
    Class 2
  • Event Number
  • Event Date Posted
  • Event Status
  • Event Country
  • Event Terminated Date
  • Event Source
  • Event Source URL
  • 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
    Ligament Fixation Device - Product Code MBI
  • Reason
    During surgical procedure the product has the potential for separation of the plug guide. separation of the plug guide may compromise the ability of the inserter to fully drive the implant completely into the bone, which may also compromise the ability to tension the suture properly.
  • Action
    On 9/30/2010, Arthrocare notified customers via letters explaining the reason for the recall and requesting the product be returned.


  • Model / Serial
    Lot Numbers: W100166, WI00167, W100168
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    Product was released for distribution in US.
  • Product Description
    ArthroCare Opus SpeedLock Knotless Fixation Device; Catalog Number: OM-7500.
  • Manufacturer


  • Manufacturer Address
    ArthroCare Corporation, 680 Vaqueros Ave, Sunnyvale CA 94085-3523
  • Source