Home › Device types › LZD
Joint, Temporomandibular, Implant
FDA product code LZD · Class 3 · Dental
218
Registered devices
3,095
Adverse events
20
Recalls
0
510(k) clearances
Devices with this code
Stock TMJ Fossa-Eminence Prosthesis (RIGHT 43) — Nexus Cmf, L.L.C.Patient-Fitted TMJ Reconstructive Prosthesis System — TMJ Solutions, Inc.Stock TMJ Fossa-Eminence Prosthesis (RIGHT 07) — Nexus Cmf, L.L.C.Patient-Fitted TMJ Reconstructive Prosthesis System — TMJ Solutions, Inc.TMJ SYSTEM — BIOMET MICROFIXATION, INCPatient-Fitted TMJ Reconstructive Prosthesis System — TMJ Solutions, Inc.Patient-Fitted TMJ Reconstructive Prosthesis System — TMJ Solutions, Inc.Stock TMJ Fossa-Eminence Prosthesis (RIGHT 40) — Nexus Cmf, L.L.C.Patient-Fitted TMJ Reconstructive Prosthesis System — TMJ Solutions, Inc.Patient-Specific TMJ Condylar Prosthesis (LEFT SIDE) — Nexus Cmf, L.L.C.TMJ SYSTEM — BIOMET MICROFIXATION, INC3.0 × 10.0 mm Auxiliary Screw — Nexus Cmf, L.L.C.TMJ SYSTEM — BIOMET MICROFIXATION, INCPatient-Fitted TMJ Reconstructive Prosthesis System — TMJ Solutions, Inc.Stock TMJ Fossa-Eminence Prosthesis (LEFT 20) — Nexus Cmf, L.L.C.Patient-Fitted TMJ Reconstructive Prosthesis System — TMJ Solutions, Inc.Stock TMJ Fossa-Eminence Prosthesis (LEFT 31) — Nexus Cmf, L.L.C.Patient-Fitted TMJ Reconstructive Prosthesis System — TMJ Solutions, Inc.TMJ SYSTEM — BIOMET MICROFIXATION, INCTMJ SYSTEM — BIOMET MICROFIXATION, INCTMJ SYSTEM — BIOMET MICROFIXATION, INCStock TMJ Fossa-Eminence Prosthesis (LEFT 08) — Nexus Cmf, L.L.C.Patient-Fitted TMJ Reconstructive Prosthesis System — TMJ Solutions, Inc.Stock TMJ Fossa-Eminence Prosthesis (RIGHT 42) — Nexus Cmf, L.L.C.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-02-11 | TMJ Solutions Inc | Custom temporomandibular joint implant may have contained incorrect patient-specific components that led to a poor fit of the implant, leading to a right-sided |
| 2025-10-13 | TMJ Solutions Inc | Patient-fitted temporomandibular joint implant contained discrepancy in screw hole position. |
| 2024-07-24 | TMJ Solutions Inc | Patient-fitted temporomandibular (TMJ) prothesis contained incorrect components, SterileEO |
| 2022-12-06 | Stryker Leibinger GmbH & Co. KG | Device was shipped without having regulatory approval. |
| 2018-03-12 | TMJ Solutions Inc | This device was mislabeled and is not the correct component for this patient. |
| 2014-10-17 | Biomet Microfixation, LLC | Laser etching on the parts is wider and deeper than the conditions previously validated. |
| 2014-10-17 | Biomet Microfixation, LLC | Laser etching on the parts is wider and deeper than the conditions previously validated. |
| 2014-10-17 | Biomet Microfixation, LLC | Laser etching on the parts is wider and deeper than the conditions previously validated. |
| 2014-10-17 | Biomet Microfixation, LLC | Laser etching on the parts is wider and deeper than the conditions previously validated. |
| 2014-10-17 | Biomet Microfixation, LLC | Laser etching on the parts is wider and deeper than the conditions previously validated. |
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