# FDA recall Z-1444-2018

> **TMJ Solutions Inc** · Class II · device recall initiated 2018-03-12.

## 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.

## Distribution

US Distribution to GA.

## Key facts

- **Recall number:** Z-1444-2018
- **Recalling firm:** TMJ Solutions Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-03-12
- **Report date:** 2018-04-25
- **Termination date:** 2019-07-23

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Ventura, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1444-2018

## Citation

> AI Analytics. FDA recall Z-1444-2018. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/Z-1444-2018. Source: US FDA. Licensed CC0.

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