International Medical Devices Database

Manufacturer Address
Gyrus Medical, Inc., 6655 Wedgewood Road, Suite 105, Maple Grove MN 55311
Source
USFDA
1 Event
- Recall of Device Recall GYRUS ACMI PKS PlasmaSEAL Open Forceps

One device in the database

Device Recall GYRUS ACMI PKS PlasmaSEAL Open Forceps

Model / Serial
Catalog No. 2103PK and 917015PK all production codes
Product Classification
General and Plastic Surgery Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide, Australia, Canada, Netherlands. (AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, PA, RI, SC, TN, TX, VA, WA, WI, WV).
Product Description
GYRUS ACMI PKS PlasmaSEAL Open Forceps, model 2103PK and 917015PK. Sterile EO. The device is intended to be used with the PlasmaKinetic electrosurgical generator, software version 1.93 or greater or the PlasmaKinetic with SuperPulse electrosurgical generator, software version 2.19A or greater or the G400 electrosurgical generator. Made in USA Gyrus ACMI, Gyrus Medical, Inc., 6655 Wedgwood Road, Suite 160, Maple Grove, MN 55311-3602.

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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Gyrus Medical, Inc.

One device in the database

Device Recall GYRUS ACMI PKS PlasmaSEAL Open Forceps