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FDA (Device enforcement)Recalled 2025-10-13class i

TMJ Solutions Inc: TMJ Bilateral Implant REF: CHG020 Sterile EO, Rx Only

Hazard

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

Details from the source

Reason for recall: Patient-fitted temporomandibular joint implant contained discrepancy in screw hole position. Distribution: US: IL, OR, MS, TX, OK, UT, MA, MD, NY, PA, VA, FL, CA, MN, GA OUS: Canada, Spain, Brazil, Quantity: 63 units Lot/code 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

UPC codes

07613327626551, 07613327626568, 07613327626575, 07613327626605, 07613327627749, 07613327627848

Source

Official record: FDA (Device enforcement)

Republished from the official source above; details can change — the source record controls.

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