Heraeus
4 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Heraeus and translate it into plain English — free weekly digest, optional same-day alerts.
- 2026-01-21FDA-DeviceClass IIStop using Heraeus PALACOS MV pro cement
Heraeus Medical's PALACOS MV pro bone cement systems (models 5150633 and 5150635) have experienced increased reports of ampoule breakage during use. When ampoules fail to break properly or incompletely, the cement cannot form correctly and cannot be used in surgery.
- 2026-01-21FDA-DeviceClass IIStop using Heraeus PALACOS bone cement
Heraeus Medical's PALACOS MV+G pro bone cement (models 5081290 and 5081291) may have ampoules that fail to break properly during mixing. When ampoules don't break as intended, the cement cannot form correctly and cannot be used during surgery.
- 2026-01-21FDA-DeviceClass IIStop using PALACOS R+G pro bone cement
Heraeus Medical is recalling PALACOS R+G pro bone cement (models 5081288 and 5081289) because the ampoules inside the mixing system may fail to break properly. When ampoules don't break as intended, the cement cannot be prepared correctly for use during surgery.
- 2026-01-21FDA-DeviceClass IIStop using PALACOS R pro bone cement
Heraeus Medical is recalling PALACOS R pro 40 and R pro 80 bone cement products because the ampoules (small sealed containers) inside the mixing systems may not break properly during use. When ampoules fail to break, the bone cement cannot be prepared correctly and cannot be used during surgery.
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