Integra MicroFrance Monopolar and Bipolar Electrosurgical Instruments
FDA device recall Z-1867-2016 · posted 2016-05-31 · Terminated
Recall details
- Recalling firm
- Integra LifeSciences Corp.
- Reason for recall
- Reports relating to unintended patient or operator burns or operator electric shock for some of Integra's MicroFrance electrosurgical instruments.
- Action taken
- Integra sent an "Urgent Medical Device Correction" Field Safety Notice and an addendum dated March 7, 2016 to their customers via traceable courier service.
- Root cause
- Other
- Status
- Terminated
- Product code
- GEI
- Quantity affected
- 2,487 Instruments
- Distribution
- AR, CA, CO, FL, IN, KY, MA, MI, NC, NJ, NY, NM, OH, TN, TX, WA and WI
- Date initiated
- 2016-03-07
- Date posted
- 2016-05-31
- Date terminated
- 2017-03-31
- Location
- Plainsboro, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MICRO-FRANCE ELECTROSURGICAL INSTRUMENTS, VARIOUS (K993655) | Xomed, Inc. | 1999-12-21 |