United StatesThe affected product is the TMJ Bilateral Implant REF CHG020 Sterile EO (Rx only), a patient‑fitted temporomandibular joint implant distributed in U.S. states including IL, OR, MS, TX, OK, UT, MA, MD, NY, PA, VA, FL, CA, MN, GA and in Canada, Spain and Brazil. The firm recalled 63 units because the implant contained a discrepancy in screw hole position.
What's being recalled
TMJ Bilateral Implant REF: CHG020 Sterile EO, Rx Only
Recalling firm: TMJ Solutions Inc, Ventura, CA, United States.
How to identify it
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
The hazard
Patient-fitted temporomandibular joint implant contained discrepancy in screw hole position.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
US: IL, OR, MS, TX, OK, UT, MA, MD, NY, PA, VA, FL, CA, MN, GA OUS: Canada, Spain, Brazil,
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)