Class III — Xintec Corp
| Recalling firm | XINTEC CORPORATION DBA CONVERGENT LASER TECHNOLOGIES |
|---|---|
| Registered facility | XINTEC CORPORATION (the firm's only registered facility) |
| Classification | Class III |
| Status | Terminated |
| 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. |
| 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 |
| Quantity | 45 lasers |
| Distribution | PA and VA |
| Initiated | 2017-10-29 |
| Classified | 2019-10-18 |
| Terminated | 2021-04-28 |
| Recall number | Z-0162-2020 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class III recall — Xintec Corp (Z-0162-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/83902/
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