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Z-0488-2026Class I

TMJ Solutions Inc

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
TMJ Solutions Inc
Product type
Device
Status
Ongoing
Report date
2025-11-26
Distribution
US: IL, OR, MS, TX, OK, UT, MA, MD, NY, PA, VA, FL, CA, MN, GA OUS: Canada, Spain, Brazil,
Firm state
CA
Product quantity
63 units
Initiated by
Voluntary: Firm initiated
Reason for recall

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

Product description

TMJ Bilateral Implant REF: CHG020 Sterile EO, Rx Only

Code / lot 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

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →