Z-0273-2009

Gyrus ACMI, Inc. dissector PlasmaKnife (DPK) Catalog No: 7035-3005 A single use only bipolar electrosurgical...

Name: Z-0273-2009 Gyrus ACMI, Inc. dissector PlasmaKnife (DPK) Catalog No: 7035-3005 A single use only bipolar electrosurgical...
Creator: Gyrus ACMI Corporation
Published: 2008-10-01
License: https://open.fda.gov/license/

Gyrus ACMI, Inc. / initiated 2008-10-01 / Terminated / root cause: manufacturing process

FDA source

Gyrus ACMI Corporation began a recall of Gyrus ACMI, Inc. dissector PlasmaKnife (DPK) Catalog No: 7035-3005 A single use only bipolar electrosurgical instrument with the ability to cut and coagulate... on 2008-10-01. The reason FDA records is "Sterility may be compromised". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0273-2009
Status: Terminated
Initiated: 2008-10-01
Posted: 2008-11-05
Terminated: 2012-05-07
Recalling firm: Gyrus ACMI, Inc.
Product: Gyrus ACMI, Inc. dissector PlasmaKnife (DPK) Catalog No: 7035-3005 A single use only bipolar electrosurgical instrument with the ability to cut and coagulate soft tissue in head and neck surgery within an ambient air environment.
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: Sterility may be compromised
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Gyrus ACMI initiated a voluntary recall by an Urgent: Medical Device Recall letter on 10/01/08 informing accounts of the problem, cease any further use of the affected product, remove any of the affected product service representative to obtain a Return Goods Authorization, return the product, and complete the reply form and fax it to the Regulatory Affairs Dept. so that the response can be tracked.
Quantity in commerce: 1340 units
Distribution: Worldwide Distribution --- including USA and countries of Canada, UK, Italy, Spain, Norway, Australia, and Taiwan.
Product codes and lots: Lot Numbers: 0805064, 0805102, 0805103, 0806030, 0806039, 0806187, and 0807021

Product code GEI

K041285Class IIGyrus G3 System (Generator, Assessories, Somnoplasty Electrodes and Plasmacision Electrodes)Gyrus Medical , Ltd. / cleared 2004-09-10

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)