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U.S. Department of Health and Human Services

Class 2 Device Recall AES50S

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  Class 2 Device Recall AES50S see related information
Date Initiated by Firm June 17, 2015
Date Posted November 03, 2015
Recall Status1 Terminated 3 on April 11, 2017
Recall Number Z-0205-2016
Recall Event ID 71518
510(K)Number K140578  
Product Classification Electrosurgical, cutting & coagulation & accessories - Product Code GEI
Product Arthroscopic Energy 50¿ Probe with Suction, Catalog number: AES-50S

Peoduct Usage:
For resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic surgical procedures.
Code Information 1412161, 1410201, 1410271, 1412121, and 1412081
Recalling Firm/
Manufacturer		 ConMed Corporation
525 French Rd
Utica NY 13502-5945
Manufacturer Reason
for Recall		 Probe programming error. The incorrect program can generate more heat at the surgical site, resulting in an elevated probability of tissue damage.
FDA Determined
Cause 2		 Software design (manufacturing process)
Action On June 17, 2015 Con Med Corporation distributed Urgent Device Recall Notification Letters and Recall Reply forms to their customers via courier service. The letter identified the affected product, problem and actions to be taken. Customers were instructed to examine their inventory for any of the affected lot numbers referenced on the recall notice. If any of the recalled product are in stock, customers should discontinue the use or distribution of these items. If product was further distributed, customers should notify those individuals of this recall action. Customers with questions can call Gregory Connell at 727-399-5276 or email AES50S@conmed.com. Customers should also complete and return the Recall Reply Form by mail to the address listed on the recall notice.
Quantity in Commerce 276 devices
Distribution Worldwide - US distribution in the states of FL, OH, and the country of Spain.
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 = CONMED CORPORATION
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