TX1 Tissue Removal System disposable handpieces. Product Usage: The TX1 Tissue Removal System is indicated for use in su

FDA device recall Z-1518-2013 · posted 2013-06-07 · Terminated

Recall details

Recalling firm

American Optisurgical Inc

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.

Action taken

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.

Root cause

No Marketing Application

Status

Terminated

Product code

LFL

Quantity affected

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, Maryla

Date initiated

2013-04-30

Date posted

2013-06-07

Date terminated

2014-03-24

Location

Lake Forest, CA