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U.S. Department of Health and Human Services

Class 2 Device Recall dissector PlasmaKnife (DPK)

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 Class 2 Recall
dissector PlasmaKnife (DPK)
see related information
Date Posted November 05, 2008
Recall Status1 Open
Recall Number Z-0273-2009
Recall Event ID 49554
Premarket Notification
510(K) Number
K041285 
Product Classification Electrosurgical, Cutting & Coagulation & Accessories - Product Code GEI
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.
Code Information Lot Numbers: 0805064, 0805102, 0805103, 0806030, 0806039, 0806187, and 0807021
Recalling Firm/
Manufacturer
Gyrus ACMI Corporation
136 Turnpike Road
Southborough, Massachusetts 01772
Consumer Instructions Contact the recalling firm for information
Manufacturer Reason
for Recall
Sterility may be compromised
FDA Determined
Cause 2
PRODUCTION CONTROLS: 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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = GEI and Original Applicant = GYRUS MEDICAL LTD.
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