Lower riskMedical device recall · FDA · Published December 9, 2025
PALACOS R+G pro 40/80 Dental Cement Recall: Ampoule Breakage Risk
Heraeus Medical recalls PALACOS R+G pro 40 and 80 dental cement models due to risk of unbreakable ampoules causing improper cement application. Affected units may not form proper cement dough for patients.
increase of complaints regarding the breakage of the ampoules within their device systems. An extensive investigation revealed that multiple factors have an impact on the ampoule breakage. An unfortunate combination of these influence factors can lead to unbreakable ampoules. If none or not all ampoules break, the product cannot be used on the patient since no or no appropriate cement dough is formed.
Take action
Contact the company
📍Recalling firmHeraeus Medical GmbH (Dental Division)Philipp-Reis-Str. 8 · Wehrheim, Germany
✎ GovInfoNow plain-language explainer
Heraeus Medical is recalling PALACOS R+G pro 40 and 80 dental cement products because ampoules can break unexpectedly or become unbreakable. This means the cement won't form properly on patients if any ampoules don't break, which could lead to improper dental procedures. Read more at govinfonow.com/recall/50505-palacos-r-g-pro-40-80-dental-cement-recall-ampoule.
“PALACOS R+G pro 40/80 Dental Cement Recall: Ampoule Breakage Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/50505-palacos-r-g-pro-40-80-dental-cement-recall-ampoule. Based on FDA recall #Z-1081-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1081-2026%22&limit=1).
The FDA announced on Dec. 9, 2025, that Heraeus Medical GmbH is voluntarily recalling PALACOS R+G pro 40 and PALACOS R+G pro 80 bone cement systems due to ampoule breakage issues. The agency issued recall number Z-1081-2026 for the Class II device.
How to tell if you have it
Brand: PALACOS
Product Names: PALACOS R+G pro 40, PALACOS R+G pro 80
Model/Catalog Numbers: 5081288, 5081289
Lot Codes (UDI-DI): 04260102136182, 04260102136212
The hazard
According to the FDA, an investigation revealed that multiple factors can lead to unbreakable ampoules. If the ampoules do not break appropriately, no cement dough forms, rendering the product unusable for patients.
Context
GovInfoNow's records show Heraeus Medical GmbH has two other recalls on record since March 25, 2026. Other recent recalls of similar products include Bard THORA/ PARA TRAY Recall: Lidocaine Ampoules Risk (May 21, 2026), Sagemax NexxZr T Multi A3.5 Dental Restorations Recall: Fracture Risk (Dec. 11, 2025), and Acumed Hexalob Screw Recall: Risk of Breakage During Wrist Fixation (May 28, 2026).
How to tell if you have this one
Check for PALACOS R+G pro 40 or 80 dental cement products with model numbers 5081288 or 5081289. The product description includes radiopaque poly(methyl methacrylate)-based bone cement pre-filled for dental use.
Brand
PALACOS
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
International distribution in the countries of Aland Islands, Australia, Belgium, Denmark, Finland, Germany, Ireland, Italy, Liechtenstein, Netherlands, New Zealand, Norway, Portugal, Spain, Sweden, Switzerland, United Kingdom.
Recall number
Product, codes & lots
Quantity
Z-1080-2026
Brand Name: PALACOS Product Name: PALACOS R pro 40; PALACOS R pro 80 Model/Catalog Number: 5081286; 5081287 Software Version: N/A Product Description: 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: 04260102136120; 04260102136151
—
Z-1081-2026
Brand Name: PALACOS Product Name: PALACOS R+G pro 40; PALACOS R+G pro 80 Model/Catalog Number: 5081288; 5081289 Software Version: N/A Product Description: 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: 04260102136182; 04260102136212
—
Z-1082-2026
Brand Name: PALACOS Product Name: PALACOS MV+G pro 40; PALACOS MV+G pro 80 Model/Catalog Number: 5081290; 5081291 Software Version: N/A Product Description: 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
—
Z-1083-2026
Brand Name: PALACOS Product Name: PALACOS MV pro 40; PALACOS MV pro 80 Model/Catalog Number: 5150633; 5150635 Software Version: N/A Product Description: 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
—
Based on the official FDA remedy
What to do — step by step
Check Product Model
Verify if your dental cement has model numbers 5081288 or 5081289.
How this recall unfolded
Recall timeline
FDA published this recall 43 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
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-1081-2026 (December 9, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1081-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 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.