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.
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.
The dental cement ampoules can break unexpectedly or become unbreakable due to multiple factors. If not all ampoules break, the cement won't form properly on patients, which could lead to ineffective dental procedures.
Dental professionals using PALACOS R+G pro 40 or 80 dental cement products with model numbers 5081288 or 5081289 are affected. Patients receiving dental procedures with these products may be at risk of improper cement application.
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.
Verify if your dental cement has model numbers 5081288 or 5081289.
The recall is due to complaints about ampoules breaking unexpectedly or becoming unbreakable, which can prevent proper cement formation for patients.
If not all ampoules break, the dental cement won't form properly on patients, which could lead to ineffective dental procedures.
The official 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-1081-2026 — PALACOS PALACOS Hello, I own a PALACOS that is covered by recall Z-1081-2026 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.
