Official recall notice
FDA DeviceClass IINotable
Palacos R+G pro 40 Recall (Oct 2026) – Heraeus Medical GmbH
Product: PALACOS R+G pro 40; PALACOS R+G pro 80. Model/Catalog Number: 5081288; 5081289. 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).
- Recall date
- 2026-10-07
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
Potential for monomer liquid leakage.
Product description
Potential for monomer liquid leakage.
Affected products
Lot Code: UDI-DI: 04260102136182; 04260102136212. All Batch Numbers. All Lot Numbers.