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 |
| Recall / campaign no. | 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 |
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.
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.