TMJ Solutions product recalled over labeling errors

Recall date

March 12, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

TMJ Solutions Inc recalls Patient-Fitted Temporomandibular (TMJ) Right Mandibular Component part of TMJ Reconstruction Prosthesis System. Model /…

Recall number

Z-1444-2018

FDA classification

Class II

Brand / firm

TMJ Solutions Inc

Sold / distributed

US Distribution to GA.

Why it was recalled

This device was mislabeled and is not the correct component for this patient.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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