Recall Z-0273-2009 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Gyrus ACMI Corporation
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.
| Date | Nov 5, 2008 (initiated Oct 1, 2008) |
| Status | Terminated |
| Reason | Sterility may be compromised |
| 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 | 1340 units |
| Distribution | Worldwide Distribution --- including USA and countries of Canada, UK, Italy, Spain, Norway, Australia, and Taiwan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K041285 | GYRUS G3 SYSTEM (GENERATOR, ASSESSORIES, SOMNOPLASTY ELECTRODES AND PLASMACISION ELECTRODES) Gyrus Medical , Ltd., Sep 10, 2004 |