TMJ Solutions, LLC
San Buenaventura, CA, US
TMJ Solutions, LLC appears in FDA device records in San Buenaventura, CA. FDA records list no 510(k) clearances, no PMA records and one registered establishment. As of , FDA records show 4 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2031049 | 3001237463 | TMJ Solutions, LLC | 6059 King Drive, San Buenaventura, CA 93003 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2524-2026 | TMJ Bilateral Implants, REF: CHG020 | Custom temporomandibular joint implant may have contained incorrect patient-specific components that led to a poor fit of the implant, leading to a right-sided open bite. | Class II | Open, Classified | |
| Z-0488-2026 | TMJ Bilateral Implant REF: CHG020 Sterile EO, Rx Only | Patient-fitted temporomandibular joint implant contained discrepancy in screw hole position. | Class I | Open, Classified | |
| 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. | Patient-fitted temporomandibular (TMJ) prothesis contained incorrect components, SterileEO | Class II | Open, Classified | |
| Z-1444-2018 | 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 with one or more of the following conditions: Inflammatory arthritis involving the temporomandibular joint not responsive to other modalities of treatment; Recurrent fibrous and/or bony ankylosis not responsive to other modalities of treatment; Failed tissue graft; Failed alloplastic joint reconstruction; Loss of vertical mandibular height and/or occlusal relationship due to bone resorption, trauma, developmental abnormality, or pathologic lesion | This device was mislabeled and is not the correct component for this patient. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain