Recall Z-2898-2011 ยท GXY Electrode, Cutaneous
Axiobionics, LLC
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.
| Date | Aug 1, 2011 (initiated May 27, 2011) |
| Status | Terminated |
| Reason | Premature Device Failure : Failure of the electrode sites to conduct and provide muscle stimulation due to silver fabric component failure. |
| 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 sho |
| Quantity | 35 |
| Distribution | Nationwide Distribution--USA (nationwide) including the states of AZ, GA, IL, IN, MI, MO, NY, TX, and WY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K944543 | BIOFLEX GARMENTS, ASSORTED MODELS Bioflex, Inc., Jul 19, 1995 |