Z-0606-2020 Class III Terminated
FDA device recall Z-0606-2020 was initiated by Theralase Inc. on September 26, 2019 and is designated Class III. Reason for recall: Device was shipped without a Unique Device Identification (UDI) label. The recall status is terminated (terminated December 3, 2020). Affected quantity: 41 units.
Recall Details
- Product Type
- Devices
- Report Date
- December 11, 2019
- Initiation Date
- September 26, 2019
- Termination Date
- December 3, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 41 units
Product Description
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 Pattern
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.
Code Information
Serial Numbers: 3015, 3022, 3037, 3040, 3047, 3052, 3055, 3074, 3076, 3080, 3100, 3101, 3102, 3103, 3123, 3127, 3129, 3131, 3132, 3137, 3139, 3155, 3162, 3166, 3171, 3183, 3187, 3200, 3206, 3227, 3245, 3266, 3268, 3293, 3296, 3297, 3305, 3308, 3318, 3321, 3332