Z-1175-06

GYRUS ACMI PKS PlasmaSEAL Open Forceps, model 2103PK and 917015PK. Sterile EO. The device is intended to be...

Name: Z-1175-06 GYRUS ACMI PKS PlasmaSEAL Open Forceps, model 2103PK and 917015PK. Sterile EO. The device is intended to be...
Creator: Gyrus Medical, Inc.
Published: 2006-05-15
License: https://open.fda.gov/license/

Gyrus ACMI, Inc. / initiated 2006-05-15 / Terminated

FDA source

Gyrus Medical, Inc. began a recall of GYRUS ACMI PKS PlasmaSEAL Open Forceps, model 2103PK and 917015PK. Sterile EO. The device is intended to be used with the PlasmaKinetic electrosurgical... on 2006-05-15. The reason FDA records is "Gyrus ACMI has identified a product issue wherein their PlasmaSEAL Open Forceps, models 2103PK and 917015PK, may not deliver adequate hemostasis during use. Although Gyrus ACMI has had no reports of serious injury to...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1175-06
Status: Terminated
Initiated: 2006-05-15
Posted: 2006-06-27
Terminated: 2007-01-12
Recalling firm: Gyrus ACMI, Inc.
Product: 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.
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: Gyrus ACMI has identified a product issue wherein their PlasmaSEAL Open Forceps, models 2103PK and 917015PK, may not deliver adequate hemostasis during use. Although Gyrus ACMI has had no reports of serious injury to patient, testing indicated that the possibility exists.
FDA root cause: Other
Action: US accounts were initially contacted by phone beginning 05/15/2006 and then sent a follow-up letter sent 05/31/2006. Customers were told of the issue, instructed to discontinue use of the product, told to remove all 2103PK and 917015PK devices from shelves and to quarantine product until they receive a letter with instructions to return the affected devices to Gyrus ACMI.
Quantity in commerce: 2971 (2931 domestic, 40 OUS)
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 codes and lots: Catalog No. 2103PK and 917015PK all production codes

Product code GEI

K020585Class IIZip Open Forceps with Electrosurgical CutGyrus Medical, Inc. / cleared 2002-07-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)