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PALACOS® R pro 40Recalls & reported problems

Heraeus Medical GmbH · The PALACOS® R pro system consists of a mixing and application system prefilled with PALACOS® polymer powder and monomer liquid. PALACOS® R pro is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone. · Class 2 · Implant

2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
0
Deaths reported
0
Injuries reported
0
Recalls naming it
2

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

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

4 other recalls cover devices cleared under the same FDA submission (K210607); they may or may not involve this specific model.

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-3301-2026 · 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-1080-2026 · Root cause: Under Investigation by firm · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K210607. One submission often covers many models, so check the product and lot details in each record.

  • Z-3303-2026 · Aug 20, 2026 · Open, Classified
    PALACOS MV+G pro 40; PALACOS MV+G pro 80. Model/Catalog Number: 5081290; 5081291. Radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and appl
  • Z-3302-2026 · Aug 20, 2026 · Open, Classified
    PALACOS R+G pro 40; PALACOS R+G pro 80. Model/Catalog Number: 5081288; 5081289. Radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and appli
  • Z-1081-2026 · Dec 9, 2025 · Open, Classified
    Brand Name: PALACOS Product Name: PALACOS R+G pro 40; PALACOS R+G pro 80 Model/Catalog Number: 5081288; 5081289 Software Version: N/A Product Description: Radiopaque, poly(methyl m
  • Z-1082-2026 · Dec 9, 2025 · Open, Classified
    Brand Name: PALACOS Product Name: PALACOS MV+G pro 40; PALACOS MV+G pro 80 Model/Catalog Number: 5081290; 5081291 Software Version: N/A Product Description: Radiopaque, poly(methyl

Other Bone Cement devices

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.