Heraeus Medical Recalls PALACOS R pro Bone Cement Due to Leakage Risk
Heraeus Medical is recalling PALACOS R pro 40 and 80 bone cement because of a potential for monomer liquid leakage. The recall affects 33,727 units distributed worldwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk of harm (monomer leakage) without reported injuries or illnesses, which aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Heraeus Medical GmbH (Dental Division) is recalling PALACOS R pro 40 and PALACOS R pro 80, which are radiopaque, poly (methyl methacrylate)-based (PMMA) bone cements. The products are pre-filled into a mixing and application system and are suitable for use with or without vacuum. The recall is being conducted due to a potential for monomer liquid leakage.
The recall involves 33,727 units of the product. The affected items have Model/Catalog Numbers 5081286 and 5081287. The recall covers all batch numbers and all lot numbers. The UDI-DI codes for the affected products are 04260102136120 and 04260102136151.
The products were distributed worldwide, including in the United States and numerous other countries such as Australia, Austria, Belgium, Denmark, Finland, Germany, Greece, Ireland, Italy, Japan, Liechtenstein, Malta, Netherlands, New Zealand, Norway, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland, and the United Kingdom. Consumers and healthcare providers should stop using the affected products and contact the manufacturer for further instructions.
The recalled product
- Product
- PALACOS R pro 40; PALACOS R pro 80. Model/Catalog Numbers: 5081286; 5081287. 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).
- Manufacturer
- Heraeus Medical GmbH (Dental Division)
- Category
- Medical Device — Bone Cement
- Hazard
- Affected units
- 33,727
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI-DI: 04260102136120
- 04260102136151. All Batch Numbers. All Lot Numbers.
Distribution
Distributed nationwide across the United States.
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