Heraeus Medical recalls PALACOS R pro 40 and 80 dental cement models 5081286/5081287 due to risk of unbreakable ampoules causing improper cement application. Affected users should contact for guidance.
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 R pro 40 and 80 dental cement models 5081286 and 5081287 because ampoules can become unbreakable, preventing proper cement application. This could lead to ineffective dental procedures if the cement doesn't form correctly.
The dental cement ampoules can become unbreakable due to multiple factors. If the ampoules don't break or only some break, the cement won't form properly, making it unusable for dental procedures.
Dental professionals using PALACOS R pro 40 or 80 cement models 5081286 and 5081287 are affected. Those who rely on the cement for dental procedures may face ineffective treatments if ampoules don't break properly.
Check for PALACOS R pro 40 or 80 dental cement with model numbers 5081286 or 5081287. The product includes a unique identifier (UDI-DI) starting with 04260102136120 or 04260102136151.
Identify if your PALACOS R pro 40 or 80 cement has model numbers 5081286 or 5081287.
The recall is due to ampoules potentially becoming unbreakable, which prevents proper cement formation and makes the product unusable for dental procedures.
The official recall notice does not specify a remedy or action steps beyond checking product details.
The recall indicates that if ampoules don't break, the cement cannot be used properly, so it may not be safe for dental procedures.
We’ve drafted a message you can send PALACOS to request your refund or repair — edit it as you like.
Subject: Recall Z-1080-2026 — PALACOS PALACOS Hello, I own a PALACOS that is covered by recall Z-1080-2026 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.
