PALACOS® MV pro 80Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04260102135369), received between Sep 10, 2024 and Sep 10, 2024 — classified as 1 malfunction.

2 FDA recall records name this device's identifier, 2 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Aug 20, 2026Open, Classified

   Potential for monomer liquid leakage.

   Z-3304-2026 · Root cause: Under Investigation by firm · FDA record ↗

2. Dec 9, 2025Open, Classified

   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.

   Z-1083-2026 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 10, 2024

  WHEN PREPARING THE CEMENT, THE LIQUID PORTION OF IT WOULD NOT TRANSFER TO THE POWDER. NEW CEMENT WAS OPENED AND USED; LOT NUMBER OF NEW CEMENT OPENED UNKNOWN. NO DELAY TO CASE OR HARM TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20180171 ↗