Z-2899-2011

AxioBionics Wearable TherapyFreeStep Sleeve (Right and Left) that includes 2-16 BioGel Velcro Electrodes in...

Name: Z-2899-2011 AxioBionics Wearable TherapyFreeStep Sleeve (Right and Left) that includes 2-16 BioGel Velcro Electrodes in...
Creator: Axiobionics, LLC
Published: 2011-05-27
License: https://open.fda.gov/license/

Axiobionics, LLC, Center for Neuroprosthetics / initiated 2011-05-27 / Terminated / root cause: manufacturing process

FDA source

Axiobionics, LLC began a recall of 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"... on 2011-05-27. The reason FDA records is "Premature Device Failure : Failure of the electrode sites to conduct and provide muscle stimulation due to silver fabric component failure". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2899-2011
Status: Terminated
Initiated: 2011-05-27
Posted: 2011-08-01
Terminated: 2013-08-29
Recalling firm: Axiobionics, LLC, Center for Neuroprosthetics
Product: 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.
Product code: GXY Electrode, Cutaneous
Reason for recall: Premature Device Failure : Failure of the electrode sites to conduct and provide muscle stimulation due to silver fabric component failure.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
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.
Quantity in commerce: 2
Distribution: Nationwide Distribution--USA (nationwide) including the states of AZ, GA, IL, IN, MI, MO, NY, TX, and WY.
Product codes and lots: 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 code GXY

K944543Class IIBioflex Garments, Assorted ModelsBioflex, Inc. / cleared 1995-07-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)