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U.S. Department of Health and Human Services

Class 2 Device Recall ConMed ALTRUS Thermal Tissue Fusion System

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  Class 2 Device Recall ConMed ALTRUS Thermal Tissue Fusion System see related information
Date Initiated by Firm February 20, 2014
Date Posted June 20, 2014
Recall Status1 Terminated 3 on April 07, 2017
Recall Number Z-1839-2014
Recall Event ID 67610
510(K)Number K101534  
Product Classification Electrosurgical, cutting & coagulation & accessories - Product Code GEI
Product Altrus Thermal Tissue Fusion Handpieces under the following specifications: 1) 10mm x 16 cm Catalog Number: 60-9510-001, 2) 10 mm x 23 cm Catalog Number: 60-9511-001, 3) 10 mm x 36 cm Catalog Number: 60-9512-001, 4) 5 mm x 16 cm Catalog Number 60-9520-001, 5) 5 mm x 23 cm Catalog Number 60-9521-001 and 6) 5 mm x 36 cm Catalog Number 60-9522-001. Products are packaged within cartons, 6 units per carton.
Code Information all lot codes
Recalling Firm/
Manufacturer		 ConMed Corporation
525 French Road
Utica NY 13502
Manufacturer Reason
for Recall		 ConMed Corporation initiated an Urgent Medical Device Correction for Altrus Thermal Tissue Fusion Handpieces due to risk of burns.
FDA Determined
Cause 2		 Device Design
Action On February 20, 2014 and February 28, 2014 ConMed Corporation distributed Urgent Medical Device Correction notices to their domestic and foreign customers via FedEx Priority. The notice was generated by ConMed for information purposes only. Customers are to ensure that the jaws of the energy vessel sealing device does not come in contact with unintended tissue, surfaces, or objects until the jaws have cooled sufficiently. Customers who have further distributed this product, please forward a copy of the correction notice to the recipient as appropriate. Customers will questions should contact ConMed Regulatory Affairs at (315) 624-3237 or by email at altrus@conmed.com.
Quantity in Commerce 12,653 units (10,769 domestically & 1,884 internationally)
Distribution Worldwide Distribution.
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 CORP.
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