Recall Z-0488-2026— TMJ Solutions Inc
Class I · Ongoing
Class I FDA medical device recall by TMJ Solutions Inc, initiated 2025-10-13. FDA's recall record names no specific 510(k) clearance for this event. Product: TMJ Bilateral Implant REF: CHG020 Sterile EO, Rx Only. Reason: Patient-fitted temporomandibular joint implant contained discrepancy in screw hole position..
- Recalling firm
- TMJ Solutions Inc
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2025-10-13
- Firm location
- Ventura, CA, United States
Product description
TMJ Bilateral Implant REF: CHG020 Sterile EO, Rx Only
Reason for recall
Patient-fitted temporomandibular joint implant contained discrepancy in screw hole position.
Data sourced from openFDA. This site is unofficial and independent of the FDA.