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U.S. Department of Health and Human Services

Class 2 Device Recall Smith & Nephew

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  Class 2 Device Recall Smith & Nephew see related information
Date Initiated by Firm June 19, 2006
Date Posted July 13, 2006
Recall Status1 Terminated 3 on January 10, 2008
Recall Number Z-1231-06
Recall Event ID 35766
510(K)Number K031675  
Product Classification Electrosurgical, Cutting & Coagulation & Accessories - Product Code GEI
Product Dyonics Electroblade 4.5 ELITE, Full Radius, Valleylab Generator- Compatible
Part Number: 7209700
Code Information Lot Numbers: Equal to or lower 50164304 Expanded Recall: Lot Numbers: 50164305, 50165182, 50173175, 50173176
Recalling Firm/
Manufacturer		 Smith & Nephew, Inc. Endoscopy Division
150 Minuteman Drive
Andover MA 01810-1031
For Additional Information Contact Jason Bilobram
978-474-6332
Manufacturer Reason
for Recall		 Sterility seal of the package tray may have gaps/voids compromising the sterility of the device.
FDA Determined
Cause 2		 Other
Action Smith & Nephew notified consignees by Certified letter dated 6/19/06. Accounts are requested to return product. Smith & Nephew expanded the recall on 8/2/5/06 by letter to include addtional lot numbers.
Quantity in Commerce 693 boxes/Expanded 534 units
Distribution Nationwide Foreign: Smith & Nephew Canada, Germany, France, Istanbul
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 = SMITH & NEPHEW, INC.
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