CLASS III Device recall · Reported 11 Dec 2019 · FDA Enforcement Report

Tlc-2000 Therapeutic Medical Laser System recalled by Theralase

Theralase is recalling Tlc-2000 Therapeutic Medical Laser System, Power Pack component Tlc-2002 Used for the, distributed nationwide in the US. The recall was initiated on 26 Sep 2019 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesSerial Numbers on TLC-2002 Power Pack with CE Mark without CE approval: 3012 to 3204, inclusive; and 3202 to 3350 inclusive. Serial Number 3204 was sold abroad

Quantity recalled306 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0607-2020
FDA event ID: 84168
Recalling firm: Theralase, East York
Classification: Class III
Status: Terminated
Recall initiated: 26 Sep 2019
FDA classified: 18 Feb 2020
Reported: 11 Dec 2019
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Other Reasons
Device type: Hip & Knee Implants

Timeline

26 Sep 2019	Recall initiated by company
11 Dec 2019	Published in enforcement report	+76 days
18 Feb 2020	Classified by FDA	+69 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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

Where it was distributed

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.

Nationwide Arizona California Colorado Florida Georgia Illinois Indiana Louisiana Maryland Minnesota North Carolina New Jersey New Mexico New York Oregon Wisconsin

Questions about this recall

Why was it recalled?

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.

Which lots are affected?

Serial Numbers on TLC-2002 Power Pack with CE Mark without CE approval: 3012 to 3204, inclusive; and 3202 to 3350 inclusive. Serial Number 3204 was sold abroad

Where was it sold?

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.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 84168

This product is part of a recall event; the main page for the event is TLC-2000 Therapeutic Medical Laser System, used recalled by Theralase.

Reported	Class	Recall	Company	Reason	Where
11 Dec 2019	CLASS III	TLC-2000 Therapeutic Medical Laser System, used recalled by Theralase	Theralase	Other	Nationwide

More recalls from Theralase

All 7

Reported	Class	Recall	Company	Reason	Where
4 Mar 2020Device	CLASS III	TLC-2000 Therapeutic Medical Laser System recalled by Theralase	Theralase	Other	N/A
4 Mar 2020Device	CLASS III	TLC-2000 Therapeutic Medical Laser System recalled by Theralase	Theralase	Other	N/A
4 Mar 2020Device	CLASS III	TLC-2000 Therapeutic Medical Laser System Power Pack recalled	Theralase	Device Malfunction	N/A
26 Feb 2020Device	CLASS III	TLC-2000 Therapeutic Medical Laser System recalled by Theralase	Theralase	Other
26 Feb 2020Device	CLASS III	TLC-2000 Therapeutic Medical Laser System recalled by Theralase	Theralase	Other	Nationwide

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All 3,097

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19 Aug 2026Device	CLASS II	Endo-Model, Replacement Set, Tibial Plateau, right/left, L, Uhmwpe recalled	Waldemar Link GmbH & Co. KG (Mfg Site)	Other	IN
12 Aug 2026Device	CLASS II	U2 Total Knee System Femoral offset bushing recalled	United Orthopedic	Device Malfunction	Nationwide