—#175411

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

FDA product code: GEI — Electrosurgical, Cutting & Coagulation & Accessories
Device class: Class 2
Medical specialty: General, Plastic Surgery
510(k) numbers: K083895
Affected lot / code info: Lot # J2670Y

Why it was recalled

Tips have an inadequate product insulation coating, which could result in the tips not coagulating as expected

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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

Recalling firm

Firm: Integra LifeSciences Corp.
Address: 311 Enterprise Dr, Plainsboro, New Jersey 08536-3344

Distribution

Distribution pattern: KY,NJ, RI, TX, WA Foreign: BE

Timeline

Recall initiated: 2019-07-19
Terminated: 2020-05-22
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #175411. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.