- Recalling firm
- TMJ Solutions Inc
- Reason for recall
- 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.
- Affected products (lot / model / serial)
- UDI-DI: 07613327626575, Lot: 2508181038
- Units affected
- 1
- Distribution pattern
- US Nationwide distribution in the state of MA.
- Firm location
- Ventura, CA, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-2524-2026
- Recall initiated
- February 11, 2026
- FDA classification date
- June 22, 2026
- FDA report date
- July 1, 2026
- FDA event ID
- 98509
- Last updated on HTM Vibe
- July 24, 2026