Patient-Fitted Temporomandibular — Class II medical device recall Z-1444-2018

Terminated recall by TMJ Solutions Inc, reported 2018-04-25. This device was mislabeled and is not the correct component for this patient.

Recall number	`Z-1444-2018`
Product type	Medical device
Classification	Class II
Status	Terminated
Voluntary or mandated	Voluntary
Recalling firm	TMJ Solutions Inc, Ventura, CA, United States
Recall initiated	2018-03-12
Classified	2018-04-19
Reported by FDA	2018-04-25
Terminated	2019-07-23
Quantity	1
Reason classes	labeling
Lot numbers	`W43963`
Serial numbers	`T170939RM`

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 for recall

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

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1444-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.