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Class 2 Device Recall Integra LifeSciences |
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Date Initiated by Firm |
March 07, 2016 |
Date Posted |
May 31, 2016 |
Recall Status1 |
Terminated 3 on March 31, 2017 |
Recall Number |
Z-1867-2016 |
Recall Event ID |
73684 |
510(K)Number |
K993655
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Product Classification |
Electrosurgical, cutting & coagulation & accessories - Product Code GEI
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Product |
Integra MicroFrance Monopolar and Bipolar Electrosurgical Instruments |
Code Information |
Catalogue No: CEV669E. All batch numbers distributed from January 2011 to February 17, 2016. |
Recalling Firm/ Manufacturer |
Integra LifeSciences Corp. 311 Enterprise Dr Plainsboro NJ 08536-3344
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For Additional Information Contact |
Mr. David E. Gronostajski 609-936-6822
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Manufacturer Reason for Recall |
Reports relating to unintended patient or operator burns or operator electric shock for some of Integra's MicroFrance electrosurgical instruments.
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FDA Determined Cause 2 |
Other |
Action |
Integra sent an "Urgent Medical Device Correction" Field Safety Notice and an addendum dated March 7, 2016 to their customers via traceable courier service. |
Quantity in Commerce |
2,487 Instruments |
Distribution |
AR, CA, CO, FL, IN, KY, MA, MI, NC, NJ, NY, NM, OH, TN, TX, WA and WI |
Total Product Life Cycle |
TPLC Device Report
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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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510(K) Database |
510(K)s with Product Code = GEI and Original Applicant = XOMED, INC.
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