Date Initiated by Firm | July 14, 2012 |
Date Posted | August 03, 2012 |
Recall Status1 |
Terminated 3 on March 22, 2021 |
Recall Number | Z-2144-2012 |
Recall Event ID |
62617 |
510(K)Number | K012314 |
Product Classification |
Electrosurgical, cutting & coagulation & accessories - Product Code GEI
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Product | Smith & Nephew Dyonics Electroblade Resector, 4.5mm Full Radius Blade, BONECUTTER
Part Number: 72202213
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: 950135R, 950136R, 950137R, 950138R |
Recalling Firm/ Manufacturer |
Smith & Nephew, Inc. Endoscopy Division 150 Minuteman Drive Andover MA 01810-1031
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For Additional Information Contact | Darrell Arterburn 978-749-1073 |
Manufacturer Reason for Recall | Devices 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 | 340 units |
Distribution | Worldwide Distribution - US Nationwide and the countries of : Australia, Canada, Korea, Turkey, UAE, and Japan. |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = GEI
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