FDA Device recall Z-1082-2026
Brand Name: PALACOS Product Name: PALACOS MV+G pro 40
- FDA Device
- Class II
- ongoing
- Published 2026-01-21
On 2026-01-21 the FDA classified a Class II recall of Brand Name: PALACOS Product Name: PALACOS MV+G pro 40 by Heraeus Medical Dental Division, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1082-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-12-09 |
| Published | 2026-01-21 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Heraeus Medical Dental Division |
| Distribution | n/a |
Product
Brand Name: PALACOS Product Name: PALACOS MV+G pro 40; PALACOS MV+G pro 80 Model/Catalog Number: 5081290; 5081291 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
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.
Identifiers
| code_info | Lot Code: UDI-DI: 04260102136243; 04260102136274 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1082-2026%22
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