Brand Name: PALACOS Product Name: PALACOS R pro 40; PALACOS R pro 80 Model/Cat...
Reason for Recall / Hazard
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.
Product Description & Identification
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
Affected Products
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
Additional Source Details
| Field | Value |
|---|---|
| City | Wehrheim |
| Event id | 98078 |
| Address 1 | Philipp-Reis-Str. 8 |
| Code info | Lot Code: UDI-DI: 04260102136120; 04260102136151 |
| Postal code | N/A |
| Report date | 20260121 |
| Product type | Devices |
| 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20251209 |
| Initial firm notification | |
| Center classification date | 20260114 |
Overview
- Recalling FirmHeraeus Medical GmbH (Dental Division)
- StatusOngoing
- Risk LevelClass II
- DistributionInternational 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.