Heraeus Medical recalls PALACOS MV pro 40 and 80 dental cement models 5150633/5150635 due to ampoule breakage risks that prevent proper cement application. Affected units may not form cement dough if ampoules don't break.
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 recalls PALACOS MV pro 40 and 80 dental cement models 5150633 and 5150635 because ampoules can break unexpectedly, preventing proper cement application. This means the product cannot be used safely if ampoules don't break.
The dental cement's ampoules can break unexpectedly due to multiple factors. If ampoules don't break or only some break, the cement won't form properly, making it unsafe for patient use.
Dental professionals using PALACOS MV pro 40 or 80 cement models 5150633 and 5150635. Patients receiving dental procedures with this cement are at risk if the cement fails to form properly.
Check for PALACOS MV pro 40 or 80 dental cement with model numbers 5150633 or 5150635. The product is sold with a unique identifier (UDI-DI) starting with 04260102135338 or 04260102135369.
Identify if your PALACOS MV pro 40 or 80 cement has model numbers 5150633 or 5150635.
The recall is due to ampoules breaking unexpectedly, which can prevent the cement from forming properly and being safe for patient use.
If ampoules don't break or only some break, the cement won't form the required dough, making it unsafe for dental procedures.
Check for model numbers 5150633 or 5150635 on the PALACOS MV pro 40 or 80 cement, or unique identifiers starting with 04260102135338 or 04260102135369.
We’ve drafted a message you can send PALACOS to request your refund or repair — edit it as you like.
Subject: Recall Z-1083-2026 — PALACOS PALACOS Hello, I own a PALACOS that is covered by recall Z-1083-2026 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.
