Medical Device Safety and Recalls: Use of Bone Graft Substitutes Containing Recombinant Proteins or Synthetic Peptides in Patients under Age 18 – FDA Safety Communication

["U.S. Food & Drug Administration (FDA)" <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: Medical Device Safety and Recalls: Use of Bone Graft Substitutes Containing Recombinant Proteins or Synthetic Peptides in Patients under Age 18 – FDA Safety Communication

A safety communication has been posted titled, "Use of Bone Graft Substitutes Containing Recombinant Proteins or Synthetic Peptides in Patients under Age 18."  The FDA is informing healthcare providers, patients, and parents/guardians that bone graft substitutes containing recombinant proteins or synthetic peptides should not be the first treatment considered for patients under age 18 with significant bone defects or rare bone disorders. The FDA has not approved these products for use in patients under age 18 because their bones may still be growing and using this product may cause serious injuries. The agency recommends that health providers consider other treatment options first.  To read the entire safety communication, please see: http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm430868.htm

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