TMJ Bilateral Implant Recall: Solutions CHG020
Announced 2026-07-01 · FDA
The FDA is recalling 63 units of the TMJ Bilateral Implant devices (REF: CHG020) due to a screw hole position discrepancy. The devices were distributed in multiple U.S. states and internationally to Canada, Spain, and Brazil. No corrective action is listed in the recall notice.
| Brand | TMJ Solutions Inc |
|---|---|
| Product | TMJ Bilateral Implant REF: CHG020 Sterile EO, Rx Only |
| Reason | Patient-fitted temporomandibular joint implant contained discrepancy in screw hole position. |
| Severity | critical |
| Units affected | 1 |
| Distribution | US: IL, OR, MS, TX, OK, UT, MA, MD, NY, PA, VA, FL, CA, MN, GA OUS: Canada, Spain, Brazil, |
| Agency | FDA |
WHAT YOU SHOULD DO
- If you own this implant, contact your surgeon or TMJ Solutions to determine whether your device is part of the recall using CHG020.
- Do not use or modify the implant until your surgeon provides guidance.
- Follow your surgeon's instructions for any testing, removal, or replacement as part of the recall.
- Report any adverse events or concerns to your healthcare provider and the FDA if advised.
How to identify the recalled item
| Lot / date codes | 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 |
|---|---|
| Lot / date codes | UDI-DI: 07613327626575, Lot: 2508181038 |
These are the identifiers FDA published for this recall. Most recall notices list no UPC or model number at all — if the code on your item is not shown here, that does not mean the item is excluded. Check the official notice, or contact the company.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.