Z-0162-2020 Class III Terminated
FDA device recall Z-0162-2020 was initiated by Xintec Corp on October 29, 2017 and is designated Class III. 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 plugg… The recall status is terminated (terminated April 28, 2021). Affected quantity: 45 lasers.
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