Xintec Recalls
2 recalls on record · August 9, 2017 to October 30, 2019 · Medical Devices
Recalls by year
17
19
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
October 30, 2019Medical DevicesFDA
Xintec Corp recalls OptiLITE, Products for Laser Surgery, Model # CGH1080F, 800 micron single-use holmium fiber assembly with flat tip, Lot
Hazard: 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.
August 9, 2017Medical DevicesFDA
Xintec Corp recalls OptiLITE(TM) Products for Laser Surgery, Catalog Numbers: HTM1020F, HTM1040F, HTM1060F, HTM1010F; Manufactured by CONVE
Hazard: It has been determined that the reprocessing instructions may not provide sufficiently detailed information for the cleaning, disinfection and sterilization of the products listed below. The preliminary investigation indicates that validation data related to the reprocessing of these devices may not meet newly enacted standards.