FDAClass INovember 26, 2025

TMJ Bilateral Implant recall

TMJ Bilateral Implant REF: CHG020 Sterile EO, Rx Only

Why was TMJ Bilateral Implant recalled?

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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
TMJ Bilateral Implant REF: CHG020 Sterile EO, Rx Only
Recalling firm
TMJ Solutions Inc
Quantity
63 units
Distribution
US: IL, OR, MS, TX, OK, UT, MA, MD, NY, PA, VA, FL, CA, MN, GA OUS: Canada, Spain, Brazil,
Recall date
November 26, 2025
Classification
Class I
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls