Recall Z-1866-2016— Integra LifeSciences Corp.

Name: FDA recall Z-1866-2016
Creator: U.S. Food and Drug Administration
Published: 2016-03-07

Class II · Terminated

Class II FDA medical device recall by Integra LifeSciences Corp., initiated 2016-03-07, terminated 2017-03-31. It names one FDA 510(k) clearance: K993655. Product: Integra MicroFrance Monopolar and Bipolar Electrosurgical Instruments. Reason: Reports relating to unintended patient or operator burns or operator electric shock for some of Integra's MicroFrance electrosurgical instruments..

Recalling firm: Integra LifeSciences Corp.
Classification: Class II
Status: Terminated
Initiated: 2016-03-07
Terminated: 2017-03-31
Firm location: Plainsboro, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K993655 — MICRO-FRANCE ELECTROSURGICAL INSTRUMENTS, VARIOUSXomed, Inc.·cleared 1999-12-21

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

Integra MicroFrance Monopolar and Bipolar Electrosurgical Instruments

Reason for recall

Reports relating to unintended patient or operator burns or operator electric shock for some of Integra's MicroFrance electrosurgical instruments.

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