Events

Recall of Device Recall AxioBionics Wearable Therapy FreeStep Sleeve

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

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
    59046
  • Event Risk Class
    Class 2
  • Event Number
    Z-2899-2011
  • Event Initiated Date
    2011-05-27
  • Event Date Posted
    2011-08-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-08-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100918
  • 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
    Electrode, cutaneous - Product Code GXY
  • Reason
    Premature device failure : failure of the electrode sites to conduct and provide muscle stimulation due to silver fabric component failure.
  • Action
    Axiobionics, LLC is notifying all affected customers by phone. Three attempts will be made to contact the customer by phone. Contact by telephone will be made to prescribing physician to determine if Axiobionics has latest patient contact information. If information is different, new contact information will be recorded and 3 additional attempts will be made with the new information. If the patient cannot be reached by telephone, a certified letter will be sent to the patient's address. If contacting by mail, the letter template will be provided to the FDA recall office . All patients should have been contacted by telephone, certified mail, or in person by June 10, 2011. All patients affected by the field correction will be asked the following questions to determine if their electrodes are functional and resistances are not exceeding the output capabilities of the stimulator they are using. 1. Are you using your garment? 2. Is your garment delivering the stimulation required for your therapy? 3. If the patient is using an NP4 stimulator: What are the resistance readings on each channel? 4. If the patient answers No to question 2 or states that the resistance is reading greater than 200 ohms on at least one channel in question 3, the garments will be returned to Axiobionics for repair. Garments that are not functioning correctly will be repaired first. Functioning garments will be tested by immersion into a salt bath under the given protocol to determine if the silver fabric is properly coated. Questions regarding this correction should be directed to the Axiobionics representative at 800-552-3539.

Device

Device Recall AxioBionics Wearable Therapy FreeStep Sleeve
  • Model / Serial
    Catalog numbers for the FreeStep Sleeves include 10000 and 10001 with Serial numbers 1436 and 1458. Catalog numbers for the BioGel Velcro Electrodes include118, 119, 120, 121, 122, 123, 124, 125, 126, 127, 128, 129, and 130.
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution--USA (nationwide) including the states of AZ, GA, IL, IN, MI, MO, NY, TX, and WY.
  • Product Description
    AxioBionics Wearable TherapyFreeStep Sleeve (Right and Left) that includes 2-16 BioGel Velcro Electrodes in sizes: 2"x2", 2"x2.5", 2"x3", 2"x3.5", 2"x4", 2"x5", 2"x6", 2"x8", 1.5"x3", 1.5"x5", 1.5"x6", and 1"x1.5". || Cutaneous electrode garments for neuromuscular electrical stimulation.
  • Manufacturer
    Axiobionics, LLC

Manufacturer

Axiobionics, LLC
  • Manufacturer Address
    Axiobionics, LLC, 6111 Jackson Rd, Ann Arbor MI 48103-9167
  • Manufacturer Parent Company (2017)
    Axiobionics
  • Source
    USFDA