Class I
Medical Device Recall: TMJ Bilateral Implant REF: CHG020 Sterile EO, Rx Only
TMJ Solutions Inc · October 13, 2025
Reason for Recall
Patient-fitted temporomandibular joint implant contained discrepancy in screw hole position.
Distribution
US: IL, OR, MS, TX, OK, UT, MA, MD, NY, PA, VA, FL, CA, MN, GA OUS: Canada, Spain, Brazil,
States Affected
CA, FL, GA, IL, MA, MD, MN, MS, NY, OK, OR, PA, TX, UT, VA
Quantity Affected
63 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0488-2026
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.