Z-2524-2026 Class II Ongoing
FDA device recall Z-2524-2026 was initiated by TMJ Solutions Inc on February 11, 2026 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 1.
Recall Details
- Product Type
- Devices
- Report Date
- July 1, 2026
- Initiation Date
- February 11, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1
Product Description
TMJ Bilateral Implants, REF: CHG020
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.
Distribution Pattern
US Nationwide distribution in the state of MA.
Code Information
UDI-DI: 07613327626575, Lot: 2508181038