Heraeus Medical Recalls PALACOS R+G pro Bone Cement Due to Leakage Risk
Heraeus Medical GmbH is recalling PALACOS R+G pro 40 and 80 bone cement due to a potential for monomer liquid leakage. The recall affects 59,660 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. The hazard involves a potential for monomer liquid leakage, which is a risk-of-harm product issue where specific injury reports are not detailed in the source text, fitting the criteria for a High severity score.
Plain-English summary
Heraeus Medical GmbH (Dental Division) is recalling PALACOS R+G pro 40 and PALACOS R+G pro 80 bone cement. The product is a radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement pre-filled into a mixing and application system. The recall is being conducted due to a potential for monomer liquid leakage.
The recall involves 59,660 units. The affected products have Model/Catalog Numbers 5081288 and 5081289. The recall covers all batch numbers and lot numbers, with UDI-DI codes 04260102136182 and 04260102136212.
The products were distributed worldwide, including the United States and numerous countries in Europe, Asia, and Oceania. Consumers and healthcare providers should stop using the affected products and contact the manufacturer for further instructions.
The recalled product
- Product
- PALACOS R+G pro 40; PALACOS R+G pro 80. Model/Catalog Number: 5081288; 5081289. 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
- Affected units
- 59,660
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)
- Lot Code: UDI-DI: 04260102136182
- 04260102136212. All Batch Numbers. All Lot Numbers.
Distribution
Distributed nationwide across the United States.
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