Recall Z-0273-2009
Gyrus ACMI Corporation · initiated October 1, 2008
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.
Codes / lots: Lot Numbers: 0805064, 0805102, 0805103, 0806030, 0806039, 0806187, and 0807021
Reason for recall
Sterility may be compromised
FDA-determined cause: Process control
Action taken
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.
Details
- Recall number
- Z-0273-2009
- Initiated
- October 1, 2008
- Posted by FDA
- November 5, 2008
- Terminated
- May 7, 2012
- Product code
- GEI – Electrosurgical, Cutting & Coagulation & Accessories
- Quantity
- 1340 units
- Distribution
- Worldwide Distribution --- including USA and countries of Canada, UK, Italy, Spain, Norway, Australia, and Taiwan.
- Recalling firm
- Gyrus ACMI Corporation, Southborough, MA