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.
FDA Recall Z-0273-2009 · Posted 2008-11-05
Recalling FirmGyrus ACMI Corporation
Recall StatusTerminated
Product CodeGEI
Date Initiated2008-10-01
Date Terminated2012-05-07
Product Quantity1340 units
Reason for Recall
Sterility may be compromised
Firm 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.
Root Cause
Process control
Distribution Pattern
Worldwide Distribution --- including USA and countries of Canada, UK, Italy, Spain, Norway, Australia, and Taiwan.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.