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U.S. Department of Health and Human Services

Class 2 Device Recall Integra Surgical

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  Class 2 Device Recall Integra Surgical see related information
Date Initiated by Firm October 10, 2011
Date Posted January 11, 2012
Recall Status1 Terminated 3 on October 01, 2012
Recall Number Z-0380-2012
Recall Event ID 60214
510(K)Number K864380  
Product Classification Light, surgical, fiberoptic - Product Code FST
Product Mark II Headlight module-black with short linkage
Model: 001380LXSL



Product Usage: The fiber optic headlight system Is designed to deliver illumination from a high intensity light source for surgical site illumination.
Code Information All serial numbers
Recalling Firm/
Manufacturer		 Integra LifeSciences Corp.
311 Enterprise Dr
Plainsboro NJ 08536-3344
For Additional Information Contact Jeanne Pantalion
609-275-0500
Manufacturer Reason
for Recall		 Headlight assembly (module) may become loose and separate from the headband assembly
FDA Determined
Cause 2		 Device Design
Action Integra Life Sciences notified consignees by URGENT DEVICE RECALL letter dated October 10, 2011, via FedEx, email or telephone conference calls. The letter identified the affected product, the problem, and the actions to be taken. Customers were instructed to identify and return any affected product. Customers were requested to complete and return the attached Field Corrective Action Acknowledgement Form to Integra Surgical indicating receipt and review of this notification. For assistance and additional information contact your local and Integra Sales Representative or call Integra Surgical Customer Service at 1-800-431-1123.
Quantity in Commerce 1 unit
Distribution Worldwide Distribution - USA (nationwide) including Puerto Rico, and the countries of: Africa, Algeria, Australia, Austria, Brazil, Canada, Check Republic, China, Chile, Costa Rica, Denmark, Dominican Republic, Ecuador, Ethiopia, Finland, France, Georgia, Germany, Greece Hungary, Guatemala, India, Ireland, Israel, Italy, Iraq, Japan, Jordan, Kenya, Kuwait, Lebanon, Lithuania, Macedonia, Mexico, Netherlands, New Zealand! Norway, Oman, Pakistan, Peru Philippines, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad, Turkey, Qatar, United Kingdom, Yemeni United Arab Emirates, Uruguay, and Venezuela.
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.
510(K) Database 510(K)s with Product Code = FST and Original Applicant = LUXTEC CORP.
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