FDA DeviceClass IINotable

FDA Recall: TMJ Bilateral Implants, REF: CHG020

Date: 2026-07-01
Brand: TMJ Solutions Inc
Category: Medical Device
FDA Class: Class II

Description

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.

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.

Remedy

1

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