TMJ Solutions Inc: Medical Device Recall in 2018 - (Recall #: Z-1444-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

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

Product Classification:

Class II

Date Initiated: March 12, 2018

Date Posted: April 25, 2018

Recall Number: Z-1444-2018

Event ID: 79614

Reason for Recall:

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

Status: Terminated

Product Quantity: 1

Code Information:

Lot: W43963, Serial T170939RM, UDI +B004TYYNNNNRM0/$$3191101W43963/ST170939RMF

Distribution Pattern:

US Distribution to GA.

Voluntary or Mandated:

Voluntary: Firm initiated