Official recall notice
FDA DeviceClass IINotable
FDA Recall: TMJ Bilateral Implants, REF: CHG020
- Recall date
- 2026-07-01
- Brand
- TMJ Solutions Inc
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
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.
Product 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.
Affected products
UDI-DI: 07613327626575, Lot: 2508181038