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U.S. Department of Health and Human Services

Class 2 Device Recall Smith and Nephew Inc.

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  Class 2 Device Recall Smith and Nephew Inc. see related information
Date Initiated by Firm July 14, 2012
Date Posted August 03, 2012
Recall Status1 Terminated 3 on March 22, 2021
Recall Number Z-2145-2012
Recall Event ID 62617
510(K)Number K012314  
Product Classification Electrosurgical, cutting & coagulation & accessories - Product Code GEI
Product Smith & Nephew 5.5 mm Dyonics Bonecutter ,Electroblade
Full Radius
Part Number: 7205962

Product Usage:
The Dyonics Electroblade Resector is indicated for use in arthroscopic surgical procedures of large and small articular cavities. The Dyonics Electroblade Resector is effective in soft and osseous tissue resection and in hemostasis of bleeding vessels. It is intended for arthroscopic procedures using saline solution, Ringers lactate or other conductive solutions as an irrigant under direct or video assisted fiberoptic visualization.
Code Information Lot Numbers: 655844R, 950143R, 950144R, 950145R, 950146R
Recalling Firm/
Manufacturer		 Smith & Nephew, Inc. Endoscopy Division
150 Minuteman Drive
Andover MA 01810-1031
For Additional Information Contact Darrell Arterburn
978-749-1073
Manufacturer Reason
for Recall		 Device labeled with an expiry period of 48 months instead of 36 months; an additional 12 months for which product and package reliability has not been validated.
FDA Determined
Cause 2		 Error in labeling
Action Smith & Nephew sent an Urgent - Product Recall 1st Notification Letter dated July 2012 via Federal Express to all affected customers. The letter identified the affected product, potential risk and actions to be taken. Customers were instructed to examine inventory, quarantine immediately, complete the form attached indicating the lot numbers and quantities. The letter also instructed customers to contact Smith & Nephew Returns Group at 800-343-5717 (option 3) for a Return Authorization (RA) or send an email to endo.andreturns@smith-nephew.com. They will provide customers with instructions for returning affected products and receiving a credit. Each OUS affiliate shall be notified via (email or equivalent) of the recall by Smith & Nephew Inc.; the affiliate must then notify each facility affected by the recall. For question concerning this recall call 405-917-8585 or 978-749-1630.
Quantity in Commerce 108 units
Distribution Worldwide Distribution - US Nationwide and the countries of : Australia, Canada, Korea, Turkey, UAE, and Japan.
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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