FDA Device recall Z-3304-2026
PALACOS MV pro 40
- FDA Device
- Class II
- ongoing
- Published 2026-10-07
On 2026-10-07 the FDA classified a Class II recall of PALACOS MV pro 40 by Heraeus Medical Dental Division, citing potential for monomer liquid leakage.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3304-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-08-20 |
| Published | 2026-10-07 |
| Last updated | 2026-10-13 05:30 UTC |
| Company | Heraeus Medical Dental Division |
| Distribution | US |
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
Reason
Potential for monomer liquid leakage.
Identifiers
| code_info | Lot Code: UDI-DI: 04260102135338; 04260102135369. All Batch Numbers. All Lot Numbers. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-10-13 05:30 UTC. Current status: ongoing.
Other recalls by Heraeus Medical Dental Division
- PALACOS R+G pro 40
FDA Device · Class II · 2026-10-07 · Heraeus Medical Dental Division - PALACOS R pro 40
FDA Device · Class II · 2026-10-07 · Heraeus Medical Dental Division - PALACOS MV+G pro 40
FDA Device · Class II · 2026-10-07 · Heraeus Medical Dental Division - Heraeus, PALAMIX duo
FDA Device · Class III · 2026-05-06 · Heraeus Medical Dental Division - Heraeus, PALAMIX uno
FDA Device · Class III · 2026-05-06 · Heraeus Medical Dental Division
All Heraeus Medical Dental Division recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3304-2026%22
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