FDA Medical devices recall ·
TMJ Bilateral Implants recall
- Recall number
- Z-2524-2026
- Date
- (initiated February 11, 2026)
- Company / brand
- TMJ Solutions Inc
6059 King Dr, Ventura, CA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 1
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
TMJ Bilateral Implants, REF: CHG020
Why was it recalled?
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 should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI-DI: 07613327626575, Lot: 2508181038
Distribution
US Nationwide distribution in the state of MA.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2524-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.