FDA Device recall Z-3301-2026
PALACOS R pro 40
- FDA Device
- Class II
- ongoing
- Published 2026-10-07
On 2026-10-07 the FDA classified a Class II recall of PALACOS R 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-3301-2026 |
| 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 R pro 40; PALACOS R pro 80. Model/Catalog Numbers: 5081286; 5081287. 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).
Reason
Potential for monomer liquid leakage.
Identifiers
| code_info | UDI-DI: 04260102136120, 04260102136151. 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 MV+G pro 40
FDA Device · Class II · 2026-10-07 · Heraeus Medical Dental Division - PALACOS MV 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-3301-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.