Events

Recall of BiOMBiOM Rechargeable Li Ion 22.2 V Battery and BiOM Lithium

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

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
    63646
  • Event Risk Class
    Class 2
  • Event Number
    Z-0467-2013
  • Event Initiated Date
    2012-10-26
  • Event Date Posted
    2012-12-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-09-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114411
  • 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
    Assembly, knee/shank/ankle/foot, external - Product Code ISW
  • Reason
    Battery may over-heat during charging and smoke.
  • Action
    iWalk notified customers directly by sales representatives by telephone on October 26, 2012, and instructedthem to stop use of the battery and charger and return them to iWalk. Accounts provided with Return Material Authorizations (RMA). For questions regarding this recall call 781-761-1560.

Device

BiOMBiOM Rechargeable Li Ion 22.2 V Battery and BiOM Lithium
  • Model / Serial
    Product Code: 2001249 (BiOM Battery) ,Lot number:48831 Product Code: 2001240 (Charger), Lot number: 2973
  • Product Classification
    Physical Medicine Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including OH, NC, and NY.
  • Product Description
    BiOM Rechargeable Li Ion 22.2 V Battery and BiOM Lithium Battery Charger sold as an accessory to the BiOM lower leg system: || Product Number: 2001249 BiOM Battery || Product Number: 2001240 BiOM Charger
  • Manufacturer
    iwalk inc

Manufacturer

iwalk inc
  • Manufacturer Address
    iwalk inc, 4 Crosby Dr, Bedford MA 01730-1402
  • Source
    USFDA