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
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.
- 2026-01-21FDA-DeviceClass IIStop using Heraeus PALACOS bone cement
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.
- 2026-01-21FDA-DeviceClass IIStop using PALACOS R+G pro bone cement
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.
- 2026-01-21FDA-DeviceClass IIStop using PALACOS R pro bone cement
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.
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