Class 2 Device Recall BiOMBiOM Rechargeable Li Ion 22.2 V Battery and BiOM Lithium

• Date Initiated by Firm: October 26, 2012
• Date Posted: December 04, 2012
• Recall Status: Terminated on September 26, 2014
• Recall Number: Z-0467-2013
• Recall Event ID: 63646
• Product Classification: Assembly, knee/shank/ankle/foot, external - Product Code ISW
• Product: 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
• Code Information: Product Code: 2001249 (BiOM Battery) ,Lot number:48831 Product Code: 2001240 (Charger), Lot number: 2973
• Recalling Firm/ Manufacturer: iwalk inc; 4 Crosby Dr; Bedford MA 01730-1402
• For Additional Information Contact: 781-761-1560
• Manufacturer Reason for Recall: Battery may over-heat during charging and smoke
• FDA Determined Cause: Unknown/Undetermined by firm
• 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.
• Quantity in Commerce: 21 Batteries; 9 Chargers
• Distribution: Nationwide Distribution including OH, NC, and NY.
• 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.