Heraeus Medical GmbH (Dental Division): Device Recall

Recall Details

Recall Number

Z-1081-2026

Classification

Class II

Product Type

Device

Recalling Firm

Heraeus Medical GmbH (Dental Division)

Status

Ongoing

Date Initiated

12/09/2025

Location

Wehrheim, Germany

Voluntary/Mandated

Voluntary: Firm initiated

Reason for Recall

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.

Product Description

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 methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application system, suitable for use with or without vacuum (ready to mix). Component: N/A

Distribution Pattern

International distribution in the countries of Aland Islands, Australia, Belgium, Denmark, Finland, Germany, Ireland, Italy, Liechtenstein, Netherlands, New Zealand, Norway, Portugal, Spain, Sweden, Switzerland, United Kingdom.

Other Recalls by Heraeus Medical GmbH (Dental Division)

• Class II: Risk 12/09/2025
  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.
• Class II: Risk 12/09/2025
  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.
• Class II: Risk 12/09/2025
  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.

View all recalls by Heraeus Medical GmbH (Dental Division) →