TMJ Solutions Inc FDA Recalls

3 recalls on file across devices, 1 of them Class I and 3 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
TMJ Bilateral Implants, REF: CHG020Class IIFeb 11, 2026Custom temporomandibular joint implant may have contained in	Custom temporomandibular joint implant may have contained incorrect patient-specific components that led to a	Class IIDevices	Feb 11, 2026
TMJ Bilateral Implant REF: CHG020 Sterile EO, Rx OnlyClass IOct 13, 2025Patient-fitted temporomandibular joint implant contained dis	Patient-fitted temporomandibular joint implant contained discrepancy in screw hole position.	Class IDevices	Oct 13, 2025
Stryker TMJ Unilateral Implant, REF: GHG010, consisting of the following components: Ref: CHG010AM, Anatomical Bone ModClass IIJul 24, 2024Patient-fitted temporomandibular (TMJ) prothesis contained i	Patient-fitted temporomandibular (TMJ) prothesis contained incorrect components, SterileEO	Class IIDevices	Jul 24, 2024