TMJ Bilateral Implant REF: CHG020 Sterile EO, Rx Only
⚠ Critical Alert — Stop Using Immediately
This product has been flagged with severe risks (sterility issue). Stop using it now and contact the brand or FDA for a refund, repair, or replacement.
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0488-2026.
Patient-fitted temporomandibular joint implant contained discrepancy in screw hole position.
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0488-2026.
Recall ongoing. Follow firm instructions.
✅ What you should do
- Stop using the product if you own it.
- Check the model number, lot code, or sell-by date against the recall notice above.
- Contact Tmj Solutions Inc or the retailer where you bought it for a refund, replacement, or repair.
- For the most current official instructions, visit the FDA recall page.
- If you've been hurt by this product, report the incident to FDA.
Consumer Contact (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0488-2026.
TMJ Solutions Inc
About the U.S. Food and Drug Administration
The FDA regulates drugs, medical devices, food, cosmetics, and tobacco. Adverse event reports and recall notices are the main public safety signal.
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If you had a reaction, found contamination, or experienced a labeling problem with this product, report it to the FDA. The agency uses consumer reports to track emerging safety signals and trigger recalls.
Tmj Solutions Inc Recall FAQ
Tmj Solutions Inc is the subject of a medical implants safety report: TMJ Bilateral Implant REF: CHG020 Sterile EO, Rx Only. The notice was published on October 13, 2025 by the U.S. Food and Drug Administration (FDA). Approximately 63 units are potentially affected.