CLASS II ONGOING Device recall · Reported 1 Jul 2026 · FDA Enforcement Report

TMJ Bilateral Implants recalled by TMJ Solutions

TMJ Solutions is recalling TMJ Bilateral Implants, distributed nationwide in the US. The recall was initiated on 11 Feb 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI-DI: 07613327626575, Lot: 2508181038

Quantity recalled1

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-2524-2026
FDA event ID: 98509
Recalling firm: TMJ Solutions, Ventura, CA
Classification: Class II
Status: Ongoing
Recall initiated: 11 Feb 2026
FDA classified: 22 Jun 2026
Reported: 1 Jul 2026
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

11 Feb 2026	Recall initiated by company
22 Jun 2026	Classified by FDA	+131 days
1 Jul 2026	Published in enforcement report	+9 days

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

Reason for recall

Custom temporomandibular joint implant may have contained incorrect patient-specific components that led to a poor fit of the implant, leading to a right-sided open bite.

Product as listed by the FDA

TMJ Bilateral Implants, REF: CHG020

Where it was distributed

US Nationwide distribution in the state of MA.

Nationwide Massachusetts

Questions about this recall

Is TMJ Bilateral Implants recalled?

Yes. TMJ Solutions recalled TMJ Bilateral Implants on 11 Feb 2026. The recall is Class II and its status is Ongoing. Recall number Z-2524-2026.

Why was it recalled?

Custom temporomandibular joint implant may have contained incorrect patient-specific components that led to a poor fit of the implant, leading to a right-sided open bite.

Which lots are affected?

UDI-DI: 07613327626575, Lot: 2508181038

Where was it sold?

US Nationwide distribution in the state of MA.

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 II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Reported	Class	Recall	Company	Reason	Where
26 Nov 2025Device	CLASS I	TMJ Bilateral Implant recalled by TMJ Solutions	TMJ Solutions	Sterility	15 states
2 Oct 2024Device	CLASS II	Stryker TMJ Unilateral Implant recalled by TMJ Solutions	TMJ Solutions	Sterility	Nationwide
25 Apr 2018Device	CLASS II	Patient-Fitted Temporomandibular recalled by TMJ Solutions	TMJ Solutions	Labeling Errors	GA

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