Recall Z-1866-2016 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Integra LifeSciences Corp.
Integra MicroFrance Monopolar and Bipolar Electrosurgical Instruments
| Date | May 31, 2016 (initiated Mar 7, 2016) |
| Status | Terminated |
| Reason | Reports relating to unintended patient or operator burns or operator electric shock for some of Integra's MicroFrance electrosurgical instruments. |
| Root cause | Other |
| Action | Integra sent an "Urgent Medical Device Correction" Field Safety Notice and an addendum dated March 7, 2016 to their customers via traceable courier service. |
| Quantity | 30,146 Instruments |
| Distribution | AR, CA, CO, FL, IN, KY, MA, MI, NC, NJ, NY, NM, OH, TN, TX, WA and WI |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K993655 | MICRO-FRANCE ELECTROSURGICAL INSTRUMENTS, VARIOUS Xomed, Inc., Dec 21, 1999 |