Device Recall Gyrus ACMI

Lot number: JC929332

General and Plastic Surgery Devices

2

No

Nationwide and Canada, Australia, Germany, New Zealand, Japan, India, Great Britain

Gyrus ACMI Diego Elite Tubeset; intended for cutting, coagulation, drilling, debriding, and removal of bone, and soft and hard tissue in general ENT, Sinus/Rhinology, Nasopharyngeal/Laryngology, and Head & Neck procedures. Catalog No. TS100S, Lot numbers JC929332 and below, Rx Only, STERILE EO

Lot Number: JC24165

General and Plastic Surgery Devices

2

No

Nationwide and Canada, Australia, Germany, New Zealand, Japan, India, Great Britain

Gyrus ACMI Diego Elite Tubeset, intended for cutting, coagulation, drilling, debriding, and removal of bone, and soft and hard tissue in general ENT, Sinus/Rhinology, Nasopharyngeal/Laryngology, and Head and Neck procedures. Catalog No. TS101DC, Lot numbers JC924165 and below; Rx Only, STERILE EO

Catalog No. 2103PK and 917015PK all production codes

General and Plastic Surgery Devices

2

No

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).

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.

Lot Nos. : 6236019, 6236020, 6236021, 6258015, 6297001, 6300013, 6306015, 6320041, 6326021, 6326097, 6335042, 6342008, 6349001, 6349002, 6355029, 7011002, 7011003, 7019012

Gastroenterology-Urology Devices

2

No

Worldwide distribution ----USA and countries of Canada, The Netherlands, Japan, Portugal, Columbia, South Africa, Australia, and Spain.

Gyrus ACMI Tripolar Ultra Cutting Forceps: 5 mm X 32 cm-Reference Number: TRU5-32

Lot Nos: 6236022, 6236023, 6236024

Gastroenterology-Urology Devices

2

No

Worldwide distribution ----USA and countries of Canada, The Netherlands, Japan, Portugal, Columbia, South Africa, Australia, and Spain.

Gyrus ACMI Tripolar Ultra Cutting Forceps: 10 mm X 32 cm w/rotation-Reference Number: 006689-903