Home / Recalls / Xintec Corp / Z-0162-2020

Z-0162-2020 Class III Terminated

Recalled by Xintec Corp — Alameda, CA

Recall Details

Product Type: Devices
Report Date: October 30, 2019
Initiation Date: October 29, 2017
Termination Date: April 28, 2021
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 45 lasers

Product Description

OptiLITE, Products for Laser Surgery, Model # CGH1080F, 800 micron single-use holmium fiber assembly with flat tip, Lot Number 21144, Sterilized by Sterrad Run 4149, This device is for single-use only, sterile, UDI: 00855430006036

Reason for Recall

It has been determined that a lot of fiber lasers were programmed incorrectly. As a result, the fibers from this lot will produce an error and will not allow the user to use the laser when it is plugged in.

Distribution Pattern

PA and VA

Code Information

Lot # 21144, Use by 08/10/2021