FDA recall record · openFDA

TMJ Solutions Inc

2 FDA recalls on record (2024–2025) — 2 device. 2 still ongoing.

Class I (most serious)

Class II

Class III

ongoing

How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.

Most common reasons

Patient-fitted temporomandibular joint implant contained discrepancy in screw hole position. 1

Patient-fitted temporomandibular (TMJ) prothesis contained incorrect components, SterileEO 1

Recalls

TMJ Bilateral Implant REF: CHG020 Sterile EO, Rx Only Class I 2025-10-13 Stryker TMJ Unilateral Implant, REF: GHG010, consisting of the following components: Ref: CHG010AM, Anatomical Bone Mod Class II 2024-07-24

RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.

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