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TMJ Solutions Inc recalls Patient-Fitted Temporomandibular (TMJ) Right Mandibular Component part of TMJ Reconstruction Prosthesis System. Model /
Recalled April 25, 2018 · FDA recall Z-1444-2018 · TMJ Solutions
Hazard
This device was mislabeled and is not the correct component for this patient. · FDA Class II
Units
1
Sold at
US Distribution to GA.
Description
This device was mislabeled and is not the correct component for this patient.
Product
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
Manufacturer(s)
TMJ Solutions Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →