Recall Z-1080-2026
Heraeus Medical GmbH (Dental Division) · initiated December 9, 2025
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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
Codes / lots: Lot Code: UDI-DI: 04260102136120; 04260102136151
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.
FDA-determined cause: Under Investigation by firm
Action taken
On December 9, 2025 Urgent Field Safety Notice emails were sent to customers. Actions to be taken: 1. Read this Field Safety Notice and ensure that all relevant hospital departments are informed about its content. 2. Please complete the attached customer reply form and send it to hm.fsca.medical@heraeus.com within five (5) calendar days. This form must be returned even if you no longer use the device. 3. Keep a copy of the attached customer reply form with your records in the event of a compliance audit of your facility. 4. Heraeus Medical GmbH is fully cooperating with regulatory authorities and is committed to resolving this issue efficiently. For further details regarding this field safety notice, please contact your Heraeus Medical sales representative or distributor. We regret any inconvenience caused by this action and value your cooperation and commitment to patient safety. This field safety notice was submitted to the FDA in context of the correction authority report.
Details
- Recall number
- Z-1080-2026
- Initiated
- December 9, 2025
- Posted by FDA
- January 14, 2026
- Product code
- LOD – Bone Cement
- 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.
- Recalling firm
- Heraeus Medical GmbH (Dental Division), Wehrheim
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1081-2026 Class II | Brand Name: PALACOS Product Name: PALACOS R+G pro 40; PALACOS R+G pro 80 Model/Catalog…increase of complaints regarding the breakage of the ampoules within their device systems. An extensive… | 12/09/2025Open, Classified |
| Z-1082-2026 Class II | Brand Name: PALACOS Product Name: PALACOS MV+G pro 40; PALACOS MV+G pro 80 Model/Catalog…increase of complaints regarding the breakage of the ampoules within their device systems. An extensive… | 12/09/2025Open, Classified |
| Z-1083-2026 Class II | Brand Name: PALACOS Product Name: PALACOS MV pro 40; PALACOS MV pro 80 Model/Catalog…increase of complaints regarding the breakage of the ampoules within their device systems. An extensive… | 12/09/2025Open, Classified |