TMJ Bilateral Implants recall (TMJ Solutions Inc)
Medical deviceClass IIOngoing
Summary: TMJ Solutions Inc is recalling 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.
What is being recalled
TMJ Bilateral Implants, REF: CHG020
Why
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.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
US Nationwide distribution in the state of MA.
How to tell if yours is affected
UDI-DI: 07613327626575, Lot: 2508181038
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-2524-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | February 11, 2026 |
| Reported | July 1, 2026 |
| Company | TMJ Solutions Inc |
| Company location | Ventura, CA, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 1 |
More recalls from TMJ Solutions Inc · all medical device recalls · recalls from February 2026