Recall Z-0162-2020— Xintec Corp

Name: FDA recall Z-0162-2020
Creator: U.S. Food and Drug Administration
Published: 2017-10-29

Class III · Terminated

Class III FDA medical device recall by Xintec Corp, initiated 2017-10-29, terminated 2021-04-28. It names one FDA 510(k) clearance: K992866. 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: 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..

Recalling firm: Xintec Corp
Classification: Class III
Status: Terminated
Initiated: 2017-10-29
Terminated: 2021-04-28
Firm location: Alameda, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K992866 — OPTILITE IX LASER SURGERY ACCESSORIESConvergent Laser Technologies·cleared 1999-11-18

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.