Brand Name: PALACOS Product Name: PALACOS MV pro 40 — Class II medical device recall Z-1083-2026
Ongoing recall by Heraeus Medical GmbH (Dental Division), reported 2026-01-21. increase of complaints regarding the breakage of the ampoules within their device systems. An extensive invest
| Recall number | Z-1083-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Heraeus Medical GmbH (Dental Division), Wehrheim, Germany |
| Recall initiated | 2025-12-09 |
| Classified | 2026-01-14 |
| Reported by FDA | 2026-01-21 |
| Countries outside the US | AU, BE, CH, DE, DK, ES, FI, GB, IE, IT, NL, NO, NZ, PT, SE |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 04260102135338, 04260102135369 |
| Model numbers | 5150633 |
Product
Brand Name: PALACOS Product Name: PALACOS MV pro 40; PALACOS MV pro 80 Model/Catalog Number: 5150633; 5150635 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
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1083-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.