PlainRecalls
FDA Devices Moderate Class II Terminated

Integra MicroFrance Monopolar and Bipolar Electrosurgical Instruments

Reported: June 8, 2016 Initiated: March 7, 2016 #Z-1867-2016

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.

Details

Units Affected
2,487 Instruments
Distribution
AR, CA, CO, FL, IN, KY, MA, MI, NC, NJ, NY, NM, OH, TN, TX, WA and WI
Location
Plainsboro, NJ

Frequently Asked Questions

What product was recalled?
Integra MicroFrance Monopolar and Bipolar Electrosurgical Instruments. Recalled by Integra LifeSciences Corp.. Units affected: 2,487 Instruments.
Why was this product recalled?
Reports relating to unintended patient or operator burns or operator electric shock for some of Integra's MicroFrance electrosurgical instruments.
Which agency issued this recall?
This recall was issued by the FDA Devices on June 8, 2016. Severity: Moderate. Recall number: Z-1867-2016.