PALACOSRecalls & reported problems across all models

We found 8 models of PALACOS by Heraeus Medical GmbH in the FDA's device registry (GUDID). Together they are named in 2 adverse event reports in the FDA's MAUDE database, received between Sep 10, 2024 and Apr 15, 2025 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Use of Device Problem” (1 report).

8 FDA recall records name at least one of these models by its device identifier, 8 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

PALACOS recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Aug 20, 2026Open, Classified

   Potential for monomer liquid leakage.

   Z-3304-2026 · Root cause: Under Investigation by firm · names 2 of these models · Recall details · FDA record ↗

2. Aug 20, 2026Open, Classified

   Potential for monomer liquid leakage.

   Z-3303-2026 · Root cause: Under Investigation by firm · names 2 of these models · Recall details · FDA record ↗

3. Aug 20, 2026Open, Classified

   Potential for monomer liquid leakage.

   Z-3302-2026 · Root cause: Under Investigation by firm · names 2 of these models · Recall details · FDA record ↗

4. Aug 20, 2026Open, Classified

   Potential for monomer liquid leakage.

   Z-3301-2026 · Root cause: Under Investigation by firm · names 2 of these models · Recall details · FDA record ↗

5. 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 · names 2 of these models · Recall details · FDA record ↗

6. 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-1082-2026 · Root cause: Under Investigation by firm · names 2 of these models · Recall details · FDA record ↗

7. 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-1081-2026 · Root cause: Under Investigation by firm · names 2 of these models · Recall details · FDA record ↗

8. 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-1080-2026 · Root cause: Under Investigation by firm · names 2 of these models · Recall details · FDA record ↗

Most reported PALACOS problems

PALACOS models

8 models, most reported first. Each model has its own page with its reports, recalls and device details.

• PALACOS® MV pro 80

  Bone Cement
  2 recalls1 report
• PALACOS® R pro 80

  Bone Cement
  2 recalls1 report
• PALACOS® MV pro 40

  Bone Cement
  2 recalls0 reports
• PALACOS® R pro 40

  Bone Cement
  2 recalls0 reports
• PALACOS® R+G pro 40

  Bone Cement, Antibiotic
  2 recalls0 reports
• PALACOS® R+G pro 80

  Bone Cement, Antibiotic
  2 recalls0 reports
• PALACOS® MV+G pro 40

  Bone Cement, Antibiotic
  2 recalls0 reports
• PALACOS® MV+G pro 80

  Bone Cement, Antibiotic
  2 recalls0 reports

Recent PALACOS adverse event reports

The 2 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryApr 15, 2025Use of Device Problem

  SUBJECT ID: (B)(6). STUDY NO: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR NECK OA. DEVICE AND PROCEDURE (RELATEDNESS). THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

  Patient problems: Insufficient Information

  MAUDE report 21840072 ↗
• 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 ↗

Other Heraeus Medical GmbH products

• PALAMIX2 models · 0 reports · 2 recalls