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.
This recall has been terminated (originally issued November 5, 2008).
- Company
- Gyrus Acmi Corporation
- Recall Initiated
- October 1, 2008
- Posted
- November 5, 2008
- Terminated
- May 7, 2012
- Recall Number
- Z-0273-2009
- Quantity
- 1340 units
- Firm Location
- Southborough, MA
- Official Source
- View on FDA website ↗
Reason for Recall
Sterility may be compromised
Distribution
Worldwide Distribution --- including USA and countries of Canada, UK, Italy, Spain, Norway, Australia, and Taiwan.
Lot / Code Info
Lot Numbers: 0805064, 0805102, 0805103, 0806030, 0806039, 0806187, and 0807021
Root 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.
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