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U.S. Department of Health and Human Services

Class 2 Device Recall Integra

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  Class 2 Device Recall Integra see related information
Date Initiated by Firm June 11, 2014
Date Posted July 02, 2014
Recall Status1 Terminated 3 on December 19, 2014
Recall Number Z-1976-2014
Recall Event ID 68519
Product Classification Headlamp, operating, battery-operated - Product Code HPP
Product Integra¿ LED Battery Charger, Single Bay.
Product Number: 90523

The LED Headlight System Battery Charger (90523) is an accessory to the LED Headlight System:
90520US - LED Headlight w/Battery & AC/DC Power Supply - US
90520EU - LED Headlight w/Battery & AC/DC Power Supply - EU
90520UK - LED Headlight w/Battery & AC/DC Power Supply - UK
90520AU - LED Headlight w/Battery & AC/DC Power Supply - AU

Product Usage: The Integra LED Headlight System Is designed to provide illumination to aid visualization during minor surgical, diagnostic, or therapeutic procedures
Code Information Lot Numbers:  IE123610, IE123710, IE123810, IE123910, IE124010, IE124110, IE124210, IE124310, IE124410, IE124510, IE124610, IE124710, IE124810, IE124910, IE125010, IE125110, IE125210, IE130110, IE130210, IE130310, IE130410, IE130510, IE130610, IE130710, IE130810, IE130910, IE131010
Recalling Firm/
Manufacturer		 Integra LifeSciences Corp.
311 Enterprise Dr
Plainsboro NJ 08536-3344
For Additional Information Contact David E. Gronostajski
609-936-6822
Manufacturer Reason
for Recall		 LED battery chargers may prematurely fail and will not charge the LED battery as intended
FDA Determined
Cause 2		 Manufacturing material removal
Action Integra initiated a voluntary recall on June 11, 2014 to consignees that have been shipped affected product lots of Integra¿ LED Battery Chargers, Catalogue No. 90523. The written notifications were delivered to US consignees by traceable courier service and non-US consignees by traceable email or facsimile. The consignee notification: Advises them of the nature of the issue and the potential for an adverse patient consequence. Advises them to review their inventory and how to determine if they have affected battery chargers. Advises them to immediately stop the use or distribution of any affected product lot numbers they may have. Requests they identify and report to Integra if they do or do not have any unexpired affected product lots. Advises them replacements battery chargers will be shipped for any affected products they affirm are in their possession and how to return their affected product. Questions regarding these instructions, please contact Integra Customer Service at 1-800-431-1123 or your Integra sales
Quantity in Commerce 1250 battery chargers
Distribution Worldwide Distribution - US Nationwide and the countries of Canada, Australia, Arab Emirates, Denmark, Germany, Great Britain, India, Ireland, Israel, Japan, Kuwait, Lebanon, Malta., Netherlands, Panama, Poland, Saudi Arabia, Singapore, South Africa, Spain, Sweden, and Tunisia.
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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