FDAFDA · Food and drugs·Recall number Z-2524-2026
TMJ Bilateral Implants, REF: CHG020
Published July 1, 2026 · Recall initiated: February 11, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- TMJ Solutions Inc
- Distributor
- US Nationwide distribution in the state of MA.
- Lot
- UDI-DI: 07613327626575, Lot: 2508181038
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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