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U.S. Department of Health and Human Services

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

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  Class 2 Device Recall BiOMBiOM Rechargeable Li Ion 22.2 V Battery and BiOM Lithium see related information
Date Initiated by Firm October 26, 2012
Date Posted December 04, 2012
Recall Status1 Terminated 3 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 2		 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.
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