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Z-2524-2026Class II

TMJ Solutions Inc

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
TMJ Solutions Inc
Product type
Device
Status
Ongoing
Report date
2026-07-01
Distribution
US Nationwide distribution in the state of MA.
Firm state
CA
Product quantity
1
Initiated by
Voluntary: Firm initiated
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 description

TMJ Bilateral Implants, REF: CHG020

Code / lot info

UDI-DI: 07613327626575, Lot: 2508181038

Other recalls SPEQ maps to Documentation & Change Control
See all Documentation & Change Control recalls →

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →