Heraeus Medical Recalls PALACOS MV+G Pro Bone Cement Due to Leakage
Heraeus Medical is recalling PALACOS MV+G pro 40 and 80 bone cement due to potential monomer liquid leakage. The recall affects 20,523 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 involves a medical device with a potential for chemical leakage (monomer liquid), which poses a risk of harm to patients or users, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Heraeus Medical GmbH (Dental Division) is recalling PALACOS MV+G pro 40 and PALACOS MV+G pro 80 bone cement. These are radiopaque, poly(methyl methacrylate)-based (PMMA) bone cements pre-filled into a mixing and application system. The recall is due to a potential for monomer liquid leakage.
The recall involves 20,523 units. The products were distributed worldwide, including the United States and numerous international locations such as Australia, Austria, Belgium, and the United Kingdom. The recall covers all batch numbers and lot numbers for the specified model/catalog numbers 5081290 and 5081291.
Consumers and healthcare providers should stop using the affected products and contact Heraeus Medical for further instructions or a refund.
The recalled product
- Product
- PALACOS MV+G pro 40; PALACOS MV+G pro 80. Model/Catalog Number: 5081290; 5081291. 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
- Manufacturer
- Heraeus Medical GmbH (Dental Division)
- Category
- Medical Device — Bone Cement
- Hazard
- Affected units
- 20,523
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: 04260102136243
- 04260102136274. All Batch Numbers. All Lot Numbers.
Distribution
Distributed nationwide across the United States.
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