# FDA recall Z-1083-2026

> **Heraeus Medical GmbH (Dental Division)** · Class II · device recall initiated 2025-12-09.

## 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.

## 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.

## Key facts

- **Recall number:** Z-1083-2026
- **Recalling firm:** Heraeus Medical GmbH (Dental Division)
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-12-09
- **Report date:** 2026-01-21

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Wehrheim, Germany

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1083-2026

## Citation

> AI Analytics. FDA recall Z-1083-2026. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1083-2026. Source: US FDA. Licensed CC0.

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