Home › TMJ Solutions, Inc. › Patient-Fitted TMJ Reconstructive Prosthesis System
Patient-Fitted TMJ Reconstructive Prosthesis System
TMJ Solutions, Inc. · Model CHG026AM · UDI-DI 07613327627770
0
510(k) clearances
3,095
Adverse events (7 deaths)
20
Recalls
8
Facilities
Description
Anatomical Bone Model, Accessory
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 open bite. |
| 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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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.