Use cautionMedical device recall · FDA · Published August 20, 2026
Heraeus PALACOS MV+G pro 40 Dental Bone Cement Recall: Monomer Leakage Risk
Heraeus Medical recalls PALACOS MV+G pro 40 dental bone cement (model 5081290) due to potential monomer leakage. All units sold worldwide from 2026-08-20 are affected. Return or stop use immediately.
“Heraeus PALACOS MV+G pro 40 Dental Bone Cement Recall: Monomer Leakage Risk.” GovInfoNow, updated October 14, 2026. https://govinfonow.com/recall/1449320-heraeus-medical-gmbh-dental-division-recalls-palacos-mv-g-pro. Based on FDA recall #Z-3303-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3303-2026%22&limit=1).
The FDA announced on August 20, 2026, that Heraeus Medical GmbH (Dental Division) is recalling PALACOS MV+G pro 40 and PALACOS MV+G pro 80 bone cement due to potential monomer liquid leakage. The voluntary Class II recall affects 20,523 units distributed worldwide.
How to tell if you have it
Brand: Heraeus Medical
Product: PALACOS MV+G pro 40; PALACOS MV+G pro 80
Model/Catalog Number: 5081290; 5081291
Lot Code/UDI-DI: 04260102136243; 04260102136274
All Batch Numbers. All Lot Numbers.
The hazard
The recall cites a potential for monomer liquid leakage as the primary hazard associated with these radiopaque, poly(methyl methacrylate)-based bone cement products.
Context
GovInfoNow's records show Heraeus Medical GmbH (Dental Division) has 2 other recalls on record since 2025-12-09. Other recent recalls of similar products include PALAMIX uno mixing rod issues (2026-03-25), PALACOS R+G pro 40/80 ampoule breakage risk (2025-12-09), Stryker Single Spike Tube Set leaks (2026-06-08), Stryker AHTO Tube Set leaking (2026-06-08), and Mozarc Medical Acute High Pressure Catheter Tray packaging seal risk (2025-10-17).
How to tell if you have this one
Check for model numbers 5081290 or 5081291 on the product packaging. The product was sold worldwide starting August 20, 2026, with all batch and lot numbers included in the recall.
Brand
Heraeus Medical
Category
Medical device
FDA recall event · 4 products
All 4 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Ongoing
Distribution
Worldwide distribution - US Nationwide and the countries of Aland Islands, Australia, Austria, Belgium, Denmark, Finland, Germany, Greece, Ireland, Italy, Japan, Liechtenstein, Malta, Netherlands, New Zealand, Norway, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland, United Kingdom.
Recall number
Product, codes & lots
Quantity
Z-3301-2026
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).; UDI-DI: 04260102136120, 04260102136151. All Batch Numbers. All Lot Numbers.
33,727 units
Z-3302-2026
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).; Lot Code: UDI-DI: 04260102136182; 04260102136212. All Batch Numbers. All Lot Numbers.
59,660 units
Z-3303-2026
PALACOS MV+G pro 40; PALACOS MV+G pro 80. Model/Catalog Number: 5081290; 5081291. 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). Component: N/A; Lot Code: UDI-DI: 04260102136243; 04260102136274. All Batch Numbers. All Lot Numbers.
20,523 units
Z-3304-2026
PALACOS MV pro 40; PALACOS MV pro 80. Model/Catalog Number: 5150633; 5150635. 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). Component: N/A; Lot Code: UDI-DI: 04260102135338; 04260102135369. All Batch Numbers. All Lot Numbers.
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Based on the official FDA remedy
What to do — step by step
Check Product Details
Look for model numbers 5081290 or 5081291 on the product packaging.
Stop Using Immediately
If you have the recalled product, stop using it immediately to avoid potential monomer leakage.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide distribution - US Nationwide and the countries of Aland Islands, Australia, Austria, Belgium, Denmark, Finland, Germany, Greece, Ireland, Italy, Japan, Liechtenstein, Malta, Netherlands, New Zealand, Norway, Portugal, Slovakia,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 48 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4Added to GovInfoNow
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-3303-2026 (August 20, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3303-2026 to see it in context.
Plain-language summary written by qwen3:4b on October 14, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.