FDA ISSUE “SAFETY COMMUNICATION” OVER CERTAIN BONE GRAFT SUBSTITUTES (Orthopedics This Week)
Stop the routine use of bone graft substitutes containing recombinant proteins or synthetic peptides high-risk (Class III) medical devices in patients under 18 years of age, warns the Food and Drug Administration (FDA).
On January 21, 2015, the agency issued a “Safety Communication – Reports of Serious Injury,” because reports of serious injuries, “such as excess bone growth, fluid accumulation, inhibited bone healing, and swelling,” have increased the agency’s concern.
Younger Patients – Added Risks
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