FDA Medical devices recall ·
PALACOS Product Name: PALACOS R pro 40 recall
- Recall number
- Z-1080-2026
- Date
- (initiated December 9, 2025)
- Company / brand
- Heraeus Medical GmbH (Dental Division)
Philipp-Reis-Str. 8, Wehrheim, Germany - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Brand Name: PALACOS Product Name: PALACOS R pro 40; PALACOS R pro 80 Model/Catalog Number: 5081286; 5081287 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
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot Code: UDI-DI: 04260102136120; 04260102136151
Distribution
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.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1080-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.