TMJ Solutions Inc recalls TMJ Bilateral Implant REF: CHG020 Sterile EO
- Recalling company
- TMJ Solutions Inc
- Product
- TMJ Bilateral Implant REF: CHG020 Sterile EO, Rx Only
- Reason
- Patient-fitted temporomandibular joint implant contained discrepancy in screw hole position.
- Classification
- Class I – a reasonable probability that use will cause serious adverse health consequences or death
- Recall date
- Oct 13, 2025
- Reported
- Nov 26, 2025
- Distribution
- US: IL, OR, MS, TX, OK, UT, MA, MD, NY, PA, VA, FL, CA, MN, GA OUS: Canada, Spain, Brazil,
- Status
- Ongoing
- Quantity
- 63 units
- Lot / codes
- 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
- Company location
- Ventura, CA
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-0488-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-0488-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.