Events

Recall of The SYMBIONIC LEG

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Ossur Americas, 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
    67250
  • Event Risk Class
    Class 2
  • Event Number
    Z-1097-2014
  • Event Initiated Date
    2012-10-15
  • Event Date Posted
    2014-02-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-02-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125090
  • 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 and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
  • Extra notes in the data
  • Reason
    Ossur is recalling the symbionic leg because it is not recognizing the low battery warning signal from the symbionic leg before it powers down.
  • Action
    Ossur Americas contacted all affected customers via phone on October 15, 2012 informing them that a software update for this product is required, along with the recommended instructions to return the product. A loaner prosthetic will be provided to the patient while the software update is being implemented.

Device

The SYMBIONIC LEG
  • Model / Serial
    Symbionic Item Numbers:   SBL12002 SBL12006 SBL12012 SBL12016 SBL12102 SBL12112 SBL12202 SBL12212 SBL12902 SBL12903 SBL12912 SBL12913  Serial #s affected: 321245, 322095, 322276, 322894; 710119-710322
  • Product Classification
    Physical Medicine Devices
  • Distribution
    US Nationwide distribution.
  • Product Description
    The SYMBIONIC LEG is an integrated prosthetic leg for transfemoral and knee disarticulation amputees. || Product Usage: SYMBIONIC LEG is intended for continuous use by amputees of low to moderate impact levels that weigh less than 125 kg for foot categories 25 30 and less than 100kg for foot categories 22, 23 and 24. The system is not intended for athletic use.
  • Manufacturer
    Ossur Americas, Inc.

Manufacturer

Ossur Americas, Inc.
  • Manufacturer Address
    Ossur Americas, Inc., 19762 Pauling, Foothill Ranch CA 92610-2611
  • Manufacturer Parent Company (2017)
    Össur hf
  • Source
    USFDA