Tmj Solutions Inc: Joint, Temporomandibular, Implant
Recall Summary TMJ Solutions Inc is recalling TMJ Bilateral Implants (model CHG020) because some custom implants may contain incorrect patient-specific components that don't fit properly, potentially causing a right-sided open bite. The implants were distributed nationwide across all U.S. states and the District of Columbia. Patients who received this implant should contact their healthcare provider to determine if their device is affected.
- Recalling firm
- TMJ Solutions Inc
- 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.
- Classification
- Class III
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-02-11
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- US Nationwide distribution in the state of MA.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/2dd51090-8d22-47bb-9348-fc81846d8479