Straumann USA LLC is recalling 61 units of Emdogain dental regenerative material because products intended only for demonstration purposes may have been used in patients. The affected products include Article Numbers 440.230V10 and 475.132V10. These units were not intended for clinical use and may not meet the safety requirements for surgical placement.
Demonstration products may not be sterile or manufactured to the same clinical standards as patient-grade products. Using these items in patients could lead to infections or other adverse tissue reactions.
Intended for demonstration purposes only.
Intended for demonstration purposes only.
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.
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Sources: FDA iRES · Raw API Response
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