Recall Z-2206-2019— Integra LifeSciences Corp.

Name: FDA recall Z-2206-2019
Creator: U.S. Food and Drug Administration
Published: 2019-07-19

Class II · Terminated

Class II FDA medical device recall by Integra LifeSciences Corp., initiated 2019-07-19, terminated 2020-05-22. It names one FDA 510(k) clearance: K083895. 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. Reason: Tips have an inadequate product insulation coating, which could result in the tips not coagulating as expected.

Recalling firm: Integra LifeSciences Corp.
Classification: Class II
Status: Terminated
Initiated: 2019-07-19
Terminated: 2020-05-22
Firm location: Plainsboro, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K083895 — CODMAN ISOCOOL BIPOLAR FORCEPSCodman & Shurtleff, Inc.·cleared 2009-06-23

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.