Official recall notice

FDA DeviceClass IINotable

Palacos R pro 40 Recall (Oct 2026) – Heraeus Medical GmbH

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).

Recall date
2026-10-07
FDA class
Class II

Why it was recalled

Hazard

Potential for monomer liquid leakage.

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Product description

Potential for monomer liquid leakage.

Affected products

UDI-DI: 04260102136120, 04260102136151. All Batch Numbers. All Lot Numbers.

Verify with the official notice →
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