Recall Z-1444-2018— TMJ Solutions Inc
Class II · Terminated
Class II FDA medical device recall by TMJ Solutions Inc, initiated 2018-03-12, terminated 2019-07-23. FDA's recall record names no specific 510(k) clearance for this event. 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. Reason: This device was mislabeled and is not the correct component for this patient..
- Recalling firm
- TMJ Solutions Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-03-12
- Terminated
- 2019-07-23
- Firm location
- Ventura, CA, United States
Product description
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
Reason for recall
This device was mislabeled and is not the correct component for this patient.
Data sourced from openFDA. This site is unofficial and independent of the FDA.