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Recall Observatory FDA recall evidence

Device product

TMJ Bilateral Implants, REF: CHG020

Z-2524-2026

February 11, 2026

Class II

Product summary

Firm
TMJ Solutions Inc
Event
Event 98509
Status
Ongoing
Classification
Class II
Quantity
1
Official record key
device-enforcement:Z-2524-2026

Official wording

Reason: 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.

Code information: UDI-DI: 07613327626575, Lot: 2508181038

Distribution pattern: US Nationwide distribution in the state of MA.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.