Heraeus Medical recalls PALACOS MV+G pro 40 and 80 dental cement due to risk of unbreakable ampoules causing improper cement application. Affected units have model numbers 5081290 or 5081291.
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.
Heraeus Medical is recalling PALACOS MV+G pro 40 and 80 dental cement products because they can break in ways that prevent proper cement application. This means the cement won't form correctly on patients if ampoules don't break as intended.
The cement's ampoules can break in ways that prevent the cement from forming correctly. If the ampoules don't break as intended, the cement won't adhere properly to the patient's teeth or gums, potentially causing treatment failure.
Dental professionals using PALACOS MV+G pro 40 or 80 dental cement with model numbers 5081290 or 5081291 are affected. Patients receiving dental procedures with this cement could be at risk if the cement doesn't form properly.
Check for model numbers 5081290 or 5081291 on the PALACOS MV+G pro 40 or 80 dental cement products. These units were sold with the lot codes UDI-DI: 04260102136243 or 04260102136274.
Verify the model number on the product is 5081290 or 5081291.
The recall is due to complaints about ampoule breakage that can prevent the cement from forming correctly on patients.
If the ampoules don't break as intended, the cement won't form properly and cannot be used on patients.
The recall record does not mention any remedy or fix for this issue.
We’ve drafted a message you can send PALACOS to request your refund or repair — edit it as you like.
Subject: Recall Z-1082-2026 — PALACOS PALACOS Hello, I own a PALACOS that is covered by recall Z-1082-2026 from PALACOS. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
