Class 2 Device Recall AxioBionics Wearable Therapy BioSleeve

• Date Initiated by Firm: May 27, 2011
• Date Posted: August 01, 2011
• Recall Status: Terminated on August 29, 2013
• Recall Number: Z-2898-2011
• Recall Event ID: 59046
• 510(K)Number: k944543
• Product Classification: Electrode, cutaneous - Product Code GXY
• Product: AxioBionics Wearable Therapy Upper Extremity BioSleeve (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.
• Code Information: Catalog numbers for BioSleeve include 10200 and 10201 and Serial numbers 1466-1469, 1472, 1380, 1425, 1371-1374, 1389, 1391, 1392, 1453, 1454, 1460, 1393, 1402, 1403, 1430, 1482, 1396, 1502, 1503, 1431, 1432, 1449, 1435, 1387, 1504, 1409, 1410, 1539 and 1540. Catalog numbers for the BioGel Velcro Electrodes include118, 119, 120, 121, 122, 123, 124, 125, 126, 127, 128, 129, and 130.
• Recalling Firm/ Manufacturer: Axiobionics, LLC; 6111 Jackson Rd; Ann Arbor MI 48103-9167
• For Additional Information Contact: Kim Verardi; 800-552-3539
• Manufacturer Reason for Recall: Premature Device Failure : Failure of the electrode sites to conduct and provide muscle stimulation due to silver fabric component failure.
• FDA Determined 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: 35
• Distribution: Nationwide Distribution--USA (nationwide) including the states of AZ, GA, IL, IN, MI, MO, NY, TX, and WY.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = GXY and Original Applicant = BIOFLEX, INC.