AxioBionics Wearable TherapyFreeStep Sleeve (Right and Left) that includes 2-16 BioGel Velcro Electrodes in sizes: 2"x2"

FDA device recall Z-2899-2011 · posted 2011-08-01 · Terminated

Recall details

Recalling firm

Axiobionics, LLC

Reason for recall

Premature Device Failure : Failure of the electrode sites to conduct and provide muscle stimulation due to silver fabric component failure.

Action taken

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.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

GXY

Quantity affected

2

Distribution

Nationwide Distribution--USA (nationwide) including the states of AZ, GA, IL, IN, MI, MO, NY, TX, and WY.

Date initiated

2011-05-27

Date posted

2011-08-01

Date terminated

2013-08-29

Location

Ann Arbor, MI

Related 510(k) clearances