FDAClass II · Medical device · Recalled July 1, 2026

TMJ Bilateral Implants recall — TMJ Solutions Inc

Hazard: 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.

Class II: may cause temporary or medically reversible health consequences.

View the official FDA enforcement record (openFDA) ↗

Official recall ID: Z-2524-2026
Brand: TMJ Solutions
Classification: Class II
Units affected: 1
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Description

TMJ Bilateral Implants, REF: CHG020

Affected products

TMJ Bilateral Implants

Companies & origin

Recalling firm location: Ventura, CA, United States
Firm address: 6059 King Dr, N/A, 93003-7607

Identifying details (verbatim from the notice)

Product codes / lots: UDI-DI: 07613327626575, Lot: 2508181038
Distribution: US Nationwide distribution in the state of MA.
Firm notified the public via: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
FDA event ID: 98509
Recall initiated: February 11, 2026
FDA classified: June 22, 2026
FDA report date: July 1, 2026

Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim; the linked government source is authoritative. Source last checked July 24, 2026 at 12:00 AM UTC.

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