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Recall Observatory FDA recall evidence

Device product

Integra MicroFrance Monopolar and Bipolar Electrosurgical Instruments

Z-1867-2016

March 07, 2016

Class II

Product summary

Firm
Integra LifeSciences Corp.
Event
Event 73684
Status
Terminated
Classification
Class II
Quantity
2,487 Instruments
Official record key
device-enforcement:Z-1867-2016

Official wording

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

Code information: Catalogue No: CEV669E. All batch numbers distributed from January 2011 to February 17, 2016.

Distribution pattern: AR, CA, CO, FL, IN, KY, MA, MI, NC, NJ, NY, NM, OH, TN, TX, WA and WI

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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