# FDA recall Z-0162-2020

> **Xintec Corp** · Class III · device recall initiated 2017-10-29.

## 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 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

PA and VA

## Key facts

- **Recall number:** Z-0162-2020
- **Recalling firm:** Xintec Corp
- **Classification:** Class III
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-10-29
- **Report date:** 2019-10-30
- **Termination date:** 2021-04-28

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Alameda, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0162-2020

## Citation

> AI Analytics. FDA recall Z-0162-2020. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0162-2020. Source: US FDA. Licensed CC0.

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