TMJ Solutions Inc medical device recall: TMJ Bilateral Implant REF: CHG020 Sterile EO
Key facts
- Agency
- U.S. Food and Drug Administration (FDA)
- Program
- Medical devices
- Classification
- Class I
- Status
- Ongoing
- Event ID
- 97703
- Recall initiated
- Oct 13, 2025
- Classified by FDA
- Nov 14, 2025
- Posted in Enforcement Report
- Nov 26, 2025
- Recalling firm
- TMJ Solutions Inc
- Firm location
- Ventura, CA, United States
- Initiated by
- Voluntary: Firm initiated
- Firm notified customers by
- Letter
- Products in this event
- 1
What to do
Compare the product, lot or serial numbers below with what you have. If you use a prescription drug or medical device in this recall, talk to your pharmacist or health care provider before you stop using it, and follow the firm's instructions.
Reason for recall
Patient-fitted temporomandibular joint implant contained discrepancy in screw hole position.
What the classification means
- Class I: FDA's most serious category: there is a reasonable probability that using or being exposed to the product will cause serious health problems or death.
About this recall
The firm started this recall on Oct 13, 2025. FDA classified it 32 days later, on Nov 14, 2025. Distribution reported by FDA: US: IL, OR, MS, TX, OK, UT, MA, MD, NY, PA, VA, FL, CA, MN, GA OUS: Canada, Spain, Brazil, TMJ Solutions Inc has 4 recalls in our records.
Recalled products (1)
Z-0488-2026 Class I Ongoing
TMJ Bilateral Implant REF: CHG020 Sterile EO, Rx Only
Codes / lots: 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
Quantity: 63 units
Source and freshness
- Source
- U.S. Food and Drug Administration (FDA) Enforcement Report, via the openFDA device enforcement dataset
- Official notice
- FDA Enforcement Report, event 97703
- Raw record
- openFDA API (JSON)
- Dataset last updated by FDA
- Nov 3, 2026
- Imported by RecallRadar
- Nov 4, 2026
Enforcement Report entries describe recalls FDA has classified. They are not always the same as a company press release. If something here differs from FDA's record, FDA's record is correct — please tell us.