medical MODERATE Updated 2026-10-07

Heraeus Medical GmbH (Dental Division) recalls PALACOS R+G pro 40; PALACOS R+G pro 80. Model/Catalog Number

See all recalls from Heraeus Medical GmbH (Dental Division) →

Recalled 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).

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Hazard / Issue

Potential for monomer liquid leakage.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot Code: UDI-DI: 04260102136182; 04260102136212. All Batch Numbers. All Lot Numbers.

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.

Looking for a safe alternative?

Search Amazon for PALACOS R+G pro 40; →

If you were harmed by this recalled product, Top Class Actions lists active class action lawsuits and settlements that may apply to you.

View official government recall

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