TMJ Solutions Bilateral Implants
Custom temporomandibular joint implant may have contained incorrect patient-specific components, leading to a poor fit and a right-sided open bite.
Moderate risk
Using it may cause temporary or medically reversible health problems. Serious harm is unlikely.
FDA Class II recall · How risk is rated
What happened
TMJ Solutions Inc, of Ventura, California, began a recall of TMJ Bilateral Implants, REF: CHG020, on February 11, 2026. The FDA added the recall to its Enforcement Report and classified it on June 22, 2026, and the recall was in the FDA's weekly enforcement report on July 1, 2026. The custom temporomandibular joint implant may have contained incorrect patient-specific components that led to a poor fit, leading to a right-sided open bite. Distribution was in Massachusetts.
Summary by Recall Canary from the FDA notice.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Match the UDI-DI and reference number listed under your product.
TMJ Bilateral Implants
- UDI-DI
- 07613327626575
- 2508181038
- Reference number
- CHG020
Details
- Company began the recall
- Sold in
US Nationwide distribution in the state of Massachusetts.
- Event ID
- 98509
- Recall No.
- Z-2524-2026
- Company
- TMJ Solutions IncVentura, California
- Hazard
- Device defect
- Recall type
- Voluntary: Firm initiated
- Customers told by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
