Devices

Device Recall GYRUS ACMI, Sterile EO

Model / Serial
All product manufactured before July 28, 2014.
Product Classification
General and Plastic Surgery Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution - USA including US: AL, AZ, CA, FL, GA, HI, IL, IN, IA, KY, MA,MI,MS, NJ, NY, NC, OH, PA, SC, TN, UT, and WA. Internationally to ITALY, SPAIN, UNITED KINGDOM, and CHINA.
Product Description
GYRUS ACMI, REF 3345 -Everest BiCOAG MOLly Forceps 5mm/45cm || REF 3345PK - PKS MOLly Forceps 5mm/45cm || REF 3640 -Everest BiCOAG Macro Jaw Forceps 5mm/45cm || REF 3640PK- PKS Macro Jaw Forceps 5mm/45cm || REF 3844- Everest BiCOAG LP Scissors 5mm/45cm || REF 910010PK- PKS MOLly Forceps 5mm/45cm || Single-use, sterile devices intended for the electrosurgical coagulation, mechanical grasping, and dissection of tissue during the performance of laparoscopic and general surgical procedures.
Manufacturer
Gyrus Medical, Inc
1 Event
- Recall of Device Recall GYRUS ACMI, Sterile EO

Manufacturer

Gyrus Medical, Inc

Manufacturer Address
Gyrus Medical, Inc, 6655 Wedgwood Rd N Ste 160, Osseo MN 55311-3613
Manufacturer Parent Company (2017)
Olympus Corporation
Source
USFDA

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