# FDA recall Z-0606-2020

> **Theralase Inc.** · Class III · device recall initiated 2019-09-26.

## Product

TLC-2000 Therapeutic Medical Laser System, used for the temporary relief of knee pain.

## Reason for recall

Device was shipped without a Unique Device Identification (UDI) label.

## Distribution

Worldwide distribution - US Nationwide distribution in the states of AZ, CA, CO,  FL, GA, IL, IN, LA, MD, MN, NC, NJ, NM, NY, OR, WI and countries of AU, BH, CA, HK, JO, MX, PK, PH.

## Key facts

- **Recall number:** Z-0606-2020
- **Recalling firm:** Theralase Inc.
- **Classification:** Class III
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-09-26
- **Report date:** 2019-12-11
- **Termination date:** 2020-12-03

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** East York, Canada

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0606-2020

## Citation

> AI Analytics. FDA recall Z-0606-2020. Retrieved 2026-07-06 from https://api.ai-analytics.org/recall/Z-0606-2020. Source: US FDA. Licensed CC0.

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