Events

Recall of Device Recall Rheo Knee

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Ossur H / F.

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
    70693
  • Event Risk Class
    Class 2
  • Event Number
    Z-1322-2015
  • Event Initiated Date
    2015-02-26
  • Event Date Posted
    2015-03-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-11-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=134496
  • 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
    Assembly, knee/shank/ankle/foot, external - Product Code ISW
  • Reason
    The firm is recalling rheo knee bionic prosthetic due to it being discovered during an internal audit of the service line that devices were released for distribution without fully going through the assembly process.
  • Action
    The firm, Ossur, notified their customers of the Recall Notice via phone on February 26, 2015. The firm informed the customers about the recalled product, the problem and actions to be taken. The customers were instructed to send the unit in for service so the Acceptance testing can be performed for the unit in accordance to their process. If you have any questions, please contact Regulatory Affairs & Quality Assurance specialist at 949-382-3741 or email: kmontes@ossur.com.

Device

Device Recall Rheo Knee
  • Model / Serial
    Rheo 2 Item Number: RKN120007  Serial #s affected:  323056 321498
  • Product Classification
    Physical Medicine Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: US distribution in TN and country of: Austria.
  • Product Description
    The Rheo Knee bionic prosthetic is to be used exclusively for fittings of lower extremity amputations. RHEO KNEE uses Artificial Intelligence to continuously adapt to the users walking style and environment. The RHEO KNEE recognizes and responds immediately to changes in speed, load and terrain, restoring the users ability to walk naturally, comfortably and confidently at any speed.
  • Manufacturer
    Ossur H / F

Manufacturer

Ossur H / F
  • Manufacturer Address
    Ossur H / F, Grjothals 5, Reykjavik Iceland
  • Manufacturer Parent Company (2017)
    Össur hf
  • Source
    USFDA