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

Recall date

October 13, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0488-2026

FDA classification

Class I

Brand / firm

TMJ Solutions Inc

Sold / distributed

US: IL, OR, MS, TX, OK, UT, MA, MD, NY, PA, VA, FL, CA, MN, GA OUS: Canada, Spain, Brazil,

Why it was recalled

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

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

TMJ Bilateral Implant REF: CHG020 Sterile EO, Rx Only