FDA Device recall Z-2524-2026
TMJ Bilateral Implants, REF: CHG020
- FDA Device
- Class II
- ongoing
- Published 2026-07-01
On 2026-07-01 the FDA classified a Class II recall of TMJ Bilateral Implants, REF: CHG020 by Tmj Solutions, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2524-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-02-11 |
| Published | 2026-07-01 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Tmj Solutions |
| Distribution | US |
Product
TMJ Bilateral Implants, REF: CHG020
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.
Identifiers
| code_info | UDI-DI: 07613327626575, Lot: 2508181038 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2524-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.