Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Codman

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Codman see related information
Date Initiated by Firm July 19, 2019
Create Date August 07, 2019
Recall Status1 Terminated 3 on May 22, 2020
Recall Number Z-2206-2019
Recall Event ID 83485
510(K)Number K083895  
Product Classification Electrosurgical, cutting & coagulation & accessories - Product Code GEI
Product Codman ISOCOOL Bipolar Forceps-are indicated for cauterizing, coagulating, grasping, and manipulating tissue during general surgery, neurosurgery, ENT surgery, OB/GYN surgery, and maxillofacial / plastic surgery procedures.
Model # 8145100S
Code Information Lot # J2670Y
Recalling Firm/
Manufacturer		 Integra LifeSciences Corp.
311 Enterprise Dr
Plainsboro NJ 08536-3344
For Additional Information Contact SAME
609-275-0500
Manufacturer Reason
for Recall		 Tips have an inadequate product insulation coating, which could result in the tips not coagulating as expected
FDA Determined
Cause 2		 Under Investigation by firm
Action Integra LifeSciences issued recall letter on July 19, 2019 advising of problem, health risk and action to take: 1.Review your inventory and determine if you have any impacted lot. 2. If you do have product with an affected Lot Number, stop using the product immediately and remove the product from service. 3. Complete the attached form. If you do not have affected product, check the box, I do not have any product with the lot number. 4. If you do have affected product, check the box I do have product{s) with the lot number. Record the total quantity of affected product you have. 5. Complete the other information and Return the completed "Acknowledgement and Return Form" by email or fax indicating your receipt and review of this notification. Keep a copy of the form for your records. Customer Service will contact you and provide an RMA number and directions to return the product. A replacement order will also be placed for the quantity noted on the form. Customer Service Monday to Friday 8:00 AM - 8:00 PM EST USA: 1-800-654-2873: email: custsvcnj@integralife.com Outside USA: 781-565-1401
Quantity in Commerce 125 units
Distribution KY,NJ, RI, TX, WA Foreign: BE
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 = GEI and Original Applicant = Codman & Shurtleff, Inc.
-
-