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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 Device Recall dissector PlasmaKnife (DPK) see related information
Date Initiated by Firm October 01, 2008
Date Posted November 05, 2008
Recall Status1 Terminated 3 on May 07, 2012
Recall Number Z-0273-2009
Recall Event ID 49554
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 MA 01772
Manufacturer Reason
for Recall		 Sterility may be compromised
FDA Determined
Cause 2		 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 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = GEI and Original Applicant = GYRUS MEDICAL LTD.
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