TMJ Solutions Inc: Device Recall
Recall #Z-0488-2026 · 10/13/2025
Class I: Dangerous
Recall Details
- Recall Number
- Z-0488-2026
- Classification
- Class I
- Product Type
- Device
- Recalling Firm
- TMJ Solutions Inc
- Status
- Ongoing
- Date Initiated
- 10/13/2025
- Location
- Ventura, CA, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 27 units
Reason for Recall
Patient-fitted temporomandibular joint implant contained discrepancy in screw hole position.
Product Description
TMJ Bilateral Implant REF: CHG020 Sterile EO, Rx Only
Distribution Pattern
US: IL, OR, MS, TX, OK, UT, MA, MD, NY, PA, VA, FL, CA, MN, GA OUS: Canada, Spain, Brazil,
Other Recalls by TMJ Solutions Inc
- Class II: Risk 07/24/2024
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.