# FDA recall Z-0607-2020

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

## Product

TLC-2000 Therapeutic Medical Laser System, Power Pack component TLC-2002  Used for the temporary relief of knee pain.

## Reason for recall

Device was shipped without a Unique Device Identification (UDI) label and a separate label identifies the power pack as CE Marked when the device has not yet received the CE Mark.

## 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-0607-2020
- **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-0607-2020

## Citation

> AI Analytics. FDA recall Z-0607-2020. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0607-2020. Source: US FDA. Licensed CC0.

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