⚠ RecallRadar📷 ScanGuidesOfficial U.S. recall notices, restated plainly

TMJ Solutions Inc: TMJ Bilateral Implants, REF: CHG020

Medical DevicesSource: FDA (device) · Date: 2026-07-01

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
TMJ Solutions Inc
Product
TMJ Bilateral Implants, REF: CHG020
Reason / 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.
Classification
Class II
Status
Ongoing
Distribution / sold at
US Nationwide distribution in the state of MA.
Recall initiated
2026-02-11
Code info
UDI-DI: 07613327626575, Lot: 2508181038
Product quantity
1
Voluntary mandated
Voluntary: Firm initiated
City
Ventura
State
CA
Country
United States
Event id
98509
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