FDA recall Z-2524-2026

TMJ Solutions Inc · Class II · device

Product

TMJ Bilateral Implants, REF: CHG020

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.

Distribution

US Nationwide distribution in the state of MA.

Key facts

Status
Ongoing
Initiation date
2026-02-11
Report date
2026-07-01
Voluntary/Mandated
Voluntary: Firm initiated
Location
Ventura, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2524-2026