TMJ Solutions Inc
TMJ Solutions Inc has 4 FDA enforcement events on this register (4 product records) between 2018 and 2026: 4 device; the busiest year was 2018 with 1.
25% of its events are Class I; the most common class is Class II (3). 3 events are listed as ongoing; the recalling firm's address is in CA.
Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.
Enforcement events
| Initiated | Product (first record) | Type | Class | Records | Status |
|---|---|---|---|---|---|
| 11 Feb 2026 | TMJ Bilateral Implants, REF: CHG020 | Device | Class II | 1 | Ongoing |
| 13 Oct 2025 | TMJ Bilateral Implant REF: CHG020 Sterile EO, Rx Only | Device | Class I | 1 | Ongoing |
| 24 Jul 2024 | Stryker TMJ Unilateral Implant, REF: GHG010, consisting of the following components: Ref: CHG010AM, Anatomical Bone Model, Accessory, REF: CHG010RF, Glenoid Fossa Component, Right, REF: CHG010RM, Mandibular Component, Right. | Device | Class II | 1 | Ongoing |
| 12 Mar 2018 | Patient-Fitted Temporomandibular (TMJ) Right Mandibular Component part of TMJ Reconstruction Prosthesis System. Model /catalog # TYY-NNNNRM The TMJ Concepts Patient-Fitted TMJ Reconstruction Prosthesis System is intended to be used for the reconstruction of the temporomandibular joint. It is indicated for patients… | Device | Class II | 1 | Terminated |
By type and class
Class I: 25% of this firm's events; 18% of all events on the register.
Events by year
Questions and answers
How many FDA recalls has TMJ Solutions Inc had?
4 enforcement events (4 product records) on this register, 2018–2026: 4 device.
Are any TMJ Solutions Inc recalls ongoing?
3 events are listed as ongoing in the current openFDA export.
What class are TMJ Solutions Inc recalls?
3 Class II, 1 Class I. 25% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.
Where does this data come from?
openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.
Provenance
Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.