TMJ Bilateral Implant REF: CHG020 Sterile EO, Rx Only
FDA Device Recall #Z-0488-2026 — Class I — October 13, 2025
Recall Summary
| Recall Number | Z-0488-2026 |
| Classification | Class I — Serious risk |
| Date Initiated | October 13, 2025 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | TMJ Solutions Inc |
| Location | Ventura, CA |
| Product Type | Devices |
| Quantity | 63 units |
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.
Distribution Pattern
US: IL, OR, MS, TX, OK, UT, MA, MD, NY, PA, VA, FL, CA, MN, GA OUS: Canada, Spain, Brazil,
Lot / Code Information
UDI: 07613327626551,07613327626568,07613327626575,07613327626605,07613327627749 07613327627848/ Lot #s: 2410301062 2306091054 2312121078 2401181023 2401231058 2403191046 2404291064 2405021079 2407221023 2407241032 2408081047 2408131037 2408161043 2409031033 2409241016 2410011097 2410071065 2410091014 2410111030 2410291062 2411111012 2411121044 2411201015 2412061031 2412121062 2412201009 2501021011
Other Recalls from TMJ Solutions Inc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-3264-2024 | Class II | Stryker TMJ Unilateral Implant, REF: GHG010, c... | Jul 24, 2024 |
| Z-1444-2018 | Class II | Patient-Fitted Temporomandibular (TMJ) Right M... | Mar 12, 2018 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.