FDA recall Z-0162-2020

Xintec Corp · Class III · device

Product

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

PA and VA

Key facts

Status: Terminated
Initiation date: 2017-10-29
Report date: 2019-10-30
Termination date: 2021-04-28
Voluntary/Mandated: Voluntary: Firm initiated
Location: Alameda, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0162-2020