Heraeus Medical GmbH (Dental Division): Medical Device Recall in 2026 - (Recall #: Z-1081-2026)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2026.

Data Source: FDA.

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

Product Classification:

Class II

Date Initiated: December 9, 2025

Date Posted: January 21, 2026

Recall Number: Z-1081-2026

Event ID: 98078

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.

Status: Ongoing

Product Quantity:

Code Information:

Lot Code: UDI-DI: 04260102136182; 04260102136212

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.

Voluntary or Mandated:

Voluntary: Firm initiated