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U.S. Department of Health and Human Services

Class 2 Device Recall TX1 Tissue Removal System

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 Class 2 Recall
TX1 Tissue Removal System
see related information
Date Posted June 07, 2013
Recall Status1 Terminated on March 24, 2014
Recall Number Z-1518-2013
Recall Event ID 65108
Product Classification Instrument, Ultrasonic Surgical - Product Code LFL
Product TX1 Tissue Removal System disposable handpieces. Product Usage: The TX1 Tissue Removal System is indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft tissue are desirable, including General Surgery, Orthopedic Surgery, Laparoscopic Surgery and Plastic and Reconstructive Surgery.
Code Information Lot Numbers: 00312-07, 00713-06, 00912-01, 01813-02, 02413-04, 03113-02, 04213-01, 05113-01, 05113-02, 05512-03, 05713-03, 06313-05, 06512-08, 06513-02, 07213-04, 07912-06, 08212-07, 09412-03, 11412-06, 11612-05, 12912-04, 14512-07, 15312-03, 16412-07, 17412-01, 18712-06, 19812-13, 20212-03, 21412-03, 22212-03, 23412-06, 24112-06, 24212-04, 24912-13, 25712-01, 26912-01, 27712-05, 28512-03, 28912-03, 29612-01, 30512-02, 31112-05, 32112-03, 33112-01, 34712-05, 36612-01
Recalling Firm/
Manufacturer
American Optisurgical Inc
26902 Vista Ter
Lake Forest, California 92630-8123
Manufacturer Reason
for Recall
American Optisurgical, Inc. is recalling certain lots of TX1 Tissue Removal System disposable handpiece due to inventory being released into distribution without a cleared FDA 510(k) to cover recent product changes. Use of this product may lead to an underperformance of the device.
FDA Determined
Cause 2
PREMARKET APPROVAL: No Marketing Application
Action American Optisurgical Inc. (AOI) sent an Urgent Medical Device Recall letter along with a response sheet via USPS registered mail to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to immediately examine your inventory and quarantine product subject to recall. Once the product has been identified, return all products by FedEx to AOI using the AOI FedEx account 30655659-2, and referencing the Returned Goods Authorization (RGA) number:RGA# (to be assigned). For questions contact American Optisurgical Inc. Customer Service 949-580-1266.
Quantity in Commerce 1,436 units
Distribution Worldwide Disitribution - USA Nationwide in the states of Alabama, Arkansas, Arizona, California, Colorado, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia, Wyoming and the countries of Quezon City, Philippines, Singapore, and Panama City, Panama.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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