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.

Reason: 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.

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

Distribution pattern: 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.