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U.S. Department of Health and Human Services

Class 2 Device Recall Altrus Thermal Tissue Fusion

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  Class 2 Device Recall Altrus Thermal Tissue Fusion see related information
Date Initiated by Firm May 07, 2012
Date Posted May 29, 2012
Recall Status1 Terminated 3 on June 05, 2012
Recall Number Z-1682-2012
Recall Event ID 61821
510(K)Number K101534  
Product Classification Electrosurgical, cutting & coagulation & accessories - Product Code GEI
Product Altrus Thermal Tissue Fusion, Tissue Fusion Handpiece 10 mm O.D., 23 cm Shaft, Catalog Number 60-9511-001, Sterile/EO.

The Altrus Thermal Tissue Fusion System is comprised of a dedicated energy source and disposable handpiece used to ligate (seal) and divide (cut) blood vessels and tissue bundles that fit into the jaws of the handpiece.
Code Information Lot codes: 11GHB009, 11HHB002.
Recalling Firm/
ConMed Electrosurgery
14603 E Fremont Ave
Centennial CO 80112-4251
For Additional Information Contact Jason Mingilton
Manufacturer Reason
for Recall
The devices were distributed prior to the firm completing performance qualifications for their package sealing and adhesive bonding.
FDA Determined
Cause 2
Process control
Action ConMed Electrosurgery sent an "URGENT: DEVICE RECALL" letter dated May 2, 2012 to all affected customers. The letter identifies the product, problem,and actions to be taken by the customers. The letter instructs customers to review their inventory and to complete and return a Business Reply Form via fax to 303-699-9854.
Quantity in Commerce 36 units
Distribution Class II Recall-Nationwide Distribution-including the states of OH, GA, IL, PA, AZ, KY, FL, NY, MO, TN, TX, AL, IN, SC, MD, CT, NJ, and CA.
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.