Recall Z-2866-2017— Xintec Corp

Name: FDA recall Z-2866-2017
Creator: U.S. Food and Drug Administration
Published: 2017-06-23

Class II · Terminated

Class II FDA medical device recall by Xintec Corp, initiated 2017-06-23, terminated 2018-06-20. It names one FDA 510(k) clearance: K992866. Product: OptiLITE(TM) Products for Laser Surgery, Catalog Numbers: HTM1020F, HTM1040F, HTM1060F, HTM1010F; Manufactured by CONVERGENT LASTER TECHNOLOGIES The Odyssey 30B is approved for numerous medical procedures. Generally, the primary use of the laser (which includes the fibers) is related to urology, but ultimately it is up to the surgeon except in cases where it is contraindicated. The fibers are usually used in cases involving stones anywhere from the bladder up to the kidneys. Occasionally the laser system is used in soft tissue cases (non-cancerous tumors) in and around the urinary system.. Reason: 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..

Recalling firm: Xintec Corp
Classification: Class II
Status: Terminated
Initiated: 2017-06-23
Terminated: 2018-06-20
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(TM) Products for Laser Surgery, Catalog Numbers: HTM1020F, HTM1040F, HTM1060F, HTM1010F; Manufactured by CONVERGENT LASTER TECHNOLOGIES The Odyssey 30B is approved for numerous medical procedures. Generally, the primary use of the laser (which includes the fibers) is related to urology, but ultimately it is up to the surgeon except in cases where it is contraindicated. The fibers are usually used in cases involving stones anywhere from the bladder up to the kidneys. Occasionally the laser system is used in soft tissue cases (non-cancerous tumors) in and around the urinary system.

Reason for recall

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.

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