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Class 2 Device Recall Integra LifeSciences Integra MicroFrance Monopolar and Bipolar Electrosurgical Instruments |
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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-1866-2016 |
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's: CEV649B5, CEV649BGP, CEV649GP, CEV8649B5, CEV8649BGP, CEV646B5, CEV647B5, CEV648B5, CEV649-5B, CEV649-5N, CEV8646B5, CEV8647B5, CEV8648B5, CEV1019-5B, CEV10195C, CEV10195D, CEV1019-5N, CEV10195NA, CEV10195R, CEV1039-5-B, CEV10395D, CEV1039-5N, CEV3911, CEV3931, CEV3941, CEV3951, CEV3961, CEV3981, CEV3991, CEV8991, CEV104M, CEV114M, CEV211, CEV220, CEV391B, CEV394B, CEV395B, CEV399B, CEV899, CEV405, CEV406, CEV407, CEV460, CEV470, CEV470-1, CEV511M, CEV514M, CEV515M, MCLP20, MCLP25, MCLP30, MCLP40, CEV8649GP, DEV9649B5, CEV9649BGP, CEV9649GP, CEV8649-5-B, CEV8649-5N, CEV9646B5, CEV9647B5, CEV9648B5, CEV9649-5-B, CEV9649-5N, CEV10395R, CEV1039G5, CEV618-5N, CEV6185R, CEV638-5N, CEV6385R, CEV720BR, CEV720R, CEV7285R, CEV605-5, CEV8911, CEV8931, CEV8941, CEV8951, CEV8961, CEV8981, CEV520M, CEV525M, CEV531-3, CEV815M, CEV891M, CEV894M, CEV895M, CEV995M, CEV996M, CEV997M, CEV998M, CM107, CM110, CM111, CM111R, CM112, CM113, CM115 and CM120. 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 |
30,146 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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