Heraeus Medical GmbH (Dental Division) is recalling several PALACOS bone cement mixing and application systems, including the R pro, R+G pro, MV+G pro, and MV pro models. The recall follows an increase in complaints where the glass ampoules inside the device systems either broke incorrectly or were impossible to break. When these ampoules fail, the liquid and powder cannot mix to form the necessary bone cement dough required for surgical procedures. If the cement does not form properly, the product cannot be used on the patient during surgery.
The failure of the ampoules to break correctly prevents the formation of the surgical bone cement. This can lead to significant surgical delays while a replacement is found or, if the cement is incorrectly prepared, could compromise the effectiveness of the surgical procedure. While there have been an increase in complaints regarding this breakage issue, no specific injuries were mentioned in the recall report.
Radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application system.
Radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application system.
Radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application system.
Radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application system.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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