FDA DevicesClass II
TMJ Bilateral Implants, REF: CHG020
Published: July 1, 2026Recall ID: Z-2524-2026Category: devicesCountry: US
Reason for Recall / 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 & Identification
TMJ Bilateral Implants, REF: CHG020
Additional Source Details
| Field | Value |
|---|---|
| City | Ventura |
| State | CA |
| Event id | 98509 |
| Address 1 | 6059 King Dr |
| Address 2 | N/A |
| Code info | UDI-DI: 07613327626575, Lot: 2508181038 |
| Postal code | 93003-7607 |
| Report date | 20260701 |
| Product type | Devices |
| Product quantity | 1 |
| 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260211 |
| Initial firm notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
| Center classification date | 20260622 |
Overview
- Recalling FirmTMJ Solutions Inc
- StatusOngoing
- Risk LevelClass II
- DistributionUS Nationwide distribution in the state of MA.