Food, drugs, devices › TMJ Solutions Inc
Device recall: Stryker TMJ Unilateral Implant, REF: GHG010, consisting of the following components: Ref: CHG010AM, Anatomical Bone Mode
TMJ Solutions Inc (Ventura, CA) initiated this device recall on 24 Jul 2024; FDA lists 1 product record under event 95139, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 87% of the 970 device enforcement events initiated in 2024 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. TMJ Solutions Inc has 4 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
TMJ Solutions Inc, Ventura, CA.
Reason for recall
"Patient-fitted temporomandibular (TMJ) prothesis contained incorrect components, SterileEO"
Distribution
"US Nationwide distribution in the state of MN."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-3264-2024 | 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. | 1 | Class II | Ongoing | 2 Oct 2024 |
Context
Other enforcement events for TMJ Solutions Inc
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 11 Feb 2026 | TMJ Bilateral Implants, REF: CHG020 | Device | Class II | 1 |
| 13 Oct 2025 | TMJ Bilateral Implant REF: CHG020 Sterile EO, Rx Only | Device | Class I | 1 |
| 12 Mar 2018 | Patient-Fitted Temporomandibular (TMJ) Right Mandibular Component part of TMJ Reconstruction Prosthesis System. Model /c | Device | Class II | 1 |
All 4 events for TMJ Solutions Inc
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Patient-fitted temporomandibular (TMJ) prothesis contained incorrect components, SterileEO"
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "US Nationwide distribution in the state of MN."
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.