Reported Oct 7, 2026 · Ongoing
PALACOS R pro 40; PALACOS R pro 80. Model/Catalog Numbers: 5081286; 5081287. Radiopaque, poly (methyl…
Heraeus Medical GmbH (Dental Division)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Heraeus Medical GmbH (Dental Division) · Philipp-Reis-Str. 8 · Wehrheim
Is this the product you have?
PALACOS R pro 40PALACOS R pro 80
- Model/Catalog Numbers5081286; 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)
- Lot codes and dates
- UDI-DI04260102136120, 04260102136151. All Batch Numbers. All Lot Numbers
- Amount recalled
- 33,727 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Potential for monomer liquid leakage.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Heraeus Medical GmbH (Dental Division) recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.