Recall Z-1518-2013 ยท LFL Instrument, Ultrasonic Surgical
American Optisurgical Inc
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.
| Date | Jun 7, 2013 (initiated Apr 30, 2013) |
| Status | Terminated |
| 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. |
| Root cause | 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 |
| Quantity | 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.