Class I U.S. Food and Drug Administration

TMJ Bilateral Implant REF: CHG020 Sterile EO recall: Patient-fitted temporomandibular joint implant contained discrepancy in screw

Recall published 11 months ago

Patient-fitted temporomandibular joint implant contained discrepancy in screw hole position.

The hazard: Sterility or particulate concern

The concern here is contamination of a product that bypasses the body’s normal defences, which is why the threshold for recalling it is low.

What the notice says: Patient-fitted temporomandibular joint implant contained discrepancy in screw hole position.

Why it matters: The product was made or packaged in conditions that cannot assure sterility, or visible particles were found in it. For anything injected, infused or used in the eye, that is a direct route for contamination into the body.

Symptoms and when to call a doctor

Watch for fever, chills, pain, redness, swelling or discharge at an injection site, and for a red, painful or suddenly blurred eye after using an eye product. Any of these needs same-day medical attention. Do not wait to see whether it settles, and tell the clinician which product and lot you used so it can be reported against the recall.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Recall number
Z-0488-2026
Published
November 26, 2025
Risk level
Class I
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
TMJ Solutions Inc
Product type
Medical devices
Units affected
63 units
Distribution
California, Florida, Georgia, Illinois, Massachusetts, Maryland, Minnesota, Mississippi, New York, Oklahoma, Oregon, Pennsylvania, Texas, Utah, Virginia
Made in
United States
Lot / code info
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
UPC codes
07613327626551, 07613327626568, 07613327626575, 07613327626605, 07613327627749, 07613327627848

Products covered by this recall

TMJ Bilateral Implant REF: CHG020 Sterile EO, Rx Only

Check your product

The notice names 8 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 07613327626551
  • 07613327626568
  • 07613327626575
  • 07613327626605
  • 07613327627749
  • 07613327627848

Model or item number

On the rating label, the box or the instruction sheet.

  • CHG020 Sterile EO
  • Rx Only — UDI

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Sterility

TMJ Solutions Inc — The concern here is contamination of a product that bypasses the body’s normal defences, which is why the threshold for recalling it is low.

  1. Stop using the affected lot and check the lot number on your own carton or vial against the codes listed above.
  2. If you are a clinic or pharmacy, quarantine the stock and work it through your usual recall log.
  3. Report any infection or reaction you think the product caused to FDA MedWatch.
  4. Do not use a vial or syringe with visible particles, cloudiness or discolouration, whether or not it is on the recall list.

Getting a replacement supply

Do not let a refund question interrupt your treatment. Deal with the supply first and the money second.

  • Call the pharmacy before you run low. They can see which lot they dispensed to you and will usually swap it the same day.
  • Insurers do not normally count a recall replacement against a refill limit. If one is refused, ask the pharmacist to call it through as a recall override.
  • Over-the-counter products are refunded at the till like any other purchase; the recall notice on your phone is enough to explain the return.
  • If the manufacturer runs a direct reimbursement form, it will be linked from the official notice on this page.

Company contact: TMJ Solutions Inc — 6059 King Dr, Ventura, CA, 93003-7607

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was TMJ Solutions Inc medical devices recalled?

Patient-fitted temporomandibular joint implant contained discrepancy in screw hole position. Patient-fitted temporomandibular joint implant contained discrepancy in screw hole position.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 07613327626551, 07613327626568, 07613327626575; model number CHG020 Sterile EO, Rx Only — UDI. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Stop using the affected lot and check the lot number on your own carton or vial against the codes listed above.

Can I get my money back?

Call the pharmacy before you run low. They can see which lot they dispensed to you and will usually swap it the same day.

Which states were affected?

The notice lists California, Florida, Georgia, Illinois, Massachusetts, Maryland, Minnesota, Mississippi, New York, Oklahoma, Oregon, Pennsylvania and others.

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