Events

Recall of Device Recall 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
    67249
  • Event Risk Class
    Class 2
  • Event Number
    Z-0936-2014
  • Event Initiated Date
    2012-02-12
  • Event Date Posted
    2014-02-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-02-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125089
  • 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
    Component, external, limb, ankle/foot - Product Code ISH
  • Reason
    Ossur initiated this recall of the symbionic leg because it may have a possible defect in a small batch of electronics.
  • Action
    OSSUR contacted all affected customers via phone on February 12, 2013, informing them that a voluntary recall for this product has been implemented, along with the recommended instructions to return the product. A new replacement prosthetic will be provided to the customer. OSSUR has inspected and made appropriate modification to all inventory. ¿ssur will also further strengthen the design and our manufacturing process to ensure an even more robust product. For further questions please call (949) 303-3239.

Device

Device Recall SYMBIONIC LEG
  • Model / Serial
    Item Numbers: SBL12012, SMBL5250, SBL12903, SMBL5270, SMBL2240, SMBL5280, SMBL3260, SMBL7290, SMBL3280, Serial Numbers: 321195, 321201, 710326, 710328, 710335, 710339, 710340, 710353, 710355, 710365, 710390, 710396, 710399, 710405, 710407, 710411 and 710413
  • Product Classification
    Physical Medicine Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US Distribution including the states of AL, DC, GA, NY, NJ, OK and PA.
  • Product Description
    The Symbionic Leg is an integrated prosthetic leg for transfemoral and knee disarticulation amputees. || The prosthesis is composed of the RHEO KNEE and the PROPRIO FOOT, both already existing products from ¿ssur. Both are a battery powered micro-processor controlled prosthetic device and are connected through a shared battery. The knee and the foot have different sensor systems that provide real-time information used to control knee joint resistance and the flexion/extension of the ankle during the gait cycle. Default control parameters are provided with the device but can be manually adjusted by a certified prosthetist through software (knee), or by a certified prosthetist or the user through controls on the device itself (foot). || 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