Device recall
Z-3304-2026: PALACOS MV pro 40; PALACOS MV pro 80. Model/Catalog Number: 5150633; 5150635…
FDA device recall · Class II · Heraeus Medical GmbH (Dental Division)
Key facts
| Recall number (Z-number) | Z-3304-2026 |
|---|---|
| Recall event | 99708 |
| Product | PALACOS MV pro 40; PALACOS MV pro 80. Model/Catalog Number: 5150633; 5150635. Radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application system, suitable for use with or without vacuum (ready to mix). Component: N/A |
| Product code | LOD |
| Recalling firm | Heraeus Medical GmbH (Dental Division) |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K213812 |
| FEI number | 3006406161 |
At a glance
- 1–9 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