Z-1444-2018Class II

Patient-Fitted Temporomandibular (TMJ) Right Mandibular Component part of TMJ Reconstruction Prosthesis...

Name: Z-1444-2018 Patient-Fitted Temporomandibular (TMJ) Right Mandibular Component part of TMJ Reconstruction Prosthesis...
Creator: TMJ Solutions Inc
Published: 2018-03-12
License: https://open.fda.gov/license/

TMJ Solutions, LLC / initiated 2018-03-12 / Terminated / root cause: labeling and UDI

FDA source

TMJ Solutions Inc began a recall of Patient-Fitted Temporomandibular (TMJ) Right Mandibular Component part of TMJ Reconstruction Prosthesis System. Model /catalog # TYY-NNNNRM The TMJ Concepts... on 2018-03-12. FDA classified it as Class II and gives the reason as "This device was mislabeled and is not the correct component for this patient". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1444-2018
Classification: Class II
Status: Terminated
Initiated: 2018-03-12
Posted: 2018-04-19
Terminated: 2019-07-23
Recalling firm: TMJ Solutions, LLC
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
Product code: LZD Joint, Temporomandibular, Implant
Reason for recall: This device was mislabeled and is not the correct component for this patient.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: TMJ Concepts sent an Medical Device Recall Communication letter dated March 12, 2018. INSTRUCTIONS: The implants for this case should not be used and should be immediately quarantined. We request that you return the entire case (the anatomical bone model together with both the fossa and mandibular components) to us by FedEx Priority Overnight Delivery. Any bone screws and drills that were provided with the shipment can be retained at your hospital and do not need to be returned. For further questions, please call (805) 650-3391.
Quantity in commerce: 1
Distribution: US Distribution to GA.
Product codes and lots: Lot: W43963, Serial T170939RM, UDI +B004TYYNNNNRM0/$$3191101W43963/ST170939RMF

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1444-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1444-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-25	2018-04-19

Product code LZD

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)