Device recall
Z-2885-2017: PALLAS M/MAXIMIS 45mm MIS. Part of MAXIMIS Pedicle Screw Spinal Fixation…
FDA device recall · Class II · Valorem Surgical LLC
Key facts
| Recall number (Z-number) | Z-2885-2017 |
|---|---|
| Recall event | 77500 |
| Product | PALLAS M/MAXIMIS 45mm MIS . Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine. |
| Product code | MNI |
| Recalling firm | Valorem Surgical LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 27, 2018 |
| 510(k) numbers | K140359 |
| FEI number | 3010212187 |
At a glance
- 1–9 Linked 510(k)s
- 100–999 Products in the same recall event
- 100–999 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