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U.S. Department of Health and Human Services

Enforcement Report - Week of June 19, 2013

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Product Detail

Product Description 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.
Recall Number Z-1518-2013
Classification Class II
Code Info 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
Product Distributed Qty 1,436 units
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.

Event Detail

Event Id 65108
Product Type Devices
Status Ongoing
Recalling Firm American Optisurgical Inc
City Lake Forest
State CA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-04-30
Initial Firm Notification of Consignee or Public Letter
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.
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