Device recall
Z-1444-2018: Patient-Fitted Temporomandibular (TMJ) Right Mandibular Component part of TMJ…
FDA device recall · Class II · TMJ Solutions Inc
Key facts
| Recall number (Z-number) | Z-1444-2018 |
|---|---|
| Recall event | 79614 |
| 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… |
| Product code | LZD |
| Recalling firm | TMJ Solutions Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 23, 2019 |
| PMA numbers | P980052 |
| FEI number | 3001237463 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database