Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Patient-Fitted Temporomandibular (TMJ) Right Mandibular Component part of TMJ Reconstruction Recalled by TMJ Solutions Inc Due to Mislabeling
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact TMJ Solutions Inc directly.
Affected Products
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
Quantity: 1
Why Was This Recalled?
This device was mislabeled and is not the correct component for this patient.
Where Was This Sold?
This product was distributed to 1 state: GA
About TMJ Solutions Inc
TMJ Solutions Inc has 3 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report