TMJ Solutions Inc — TMJ Bilateral Implant REF: CHG020 Sterile EO, Rx Only
⚠️ Patient-fitted temporomandibular joint implant contained discrepancy in screw hole position.
Is this relevant to me?
- Geography
- US, IL, OR, MS, TX, OK, UT, MA, MD, NY, PA, VA, FL, CA, MN, GA
- Source agency
- FDA
- Category
- Health
- Published
- October 13, 2025
US: IL, OR, MS, TX, OK, UT, MA, MD, NY, PA, VA, FL, CA, MN, GA OUS: Canada, Spain, Brazil,
What's affected?
- Product
- TMJ Bilateral Implant REF: CHG020 Sterile EO, Rx Only
- Brand
- TMJ Solutions Inc
- Lot code
- 2410301062
Additional details
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
What should I do?
Recommended action
Class I recall. Voluntary: Firm initiated Quantity affected: 63 units.
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