FDAFebruary 13, 2019device
BIOVENTUS Bioactive Bone Graft Putty 15g Rx only/sterile. Filler device intended for use in bony voids or gaps that are not intrinsic to the stability of the bony structure. Sold under the brand names of: SIGNAFUSE, OSTEOFUSE and MEDLINE UNITE.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The firm became aware of the potential for the products' sterile pouch to be punctured during transit. The packaging failure may introduce a non-sterile device that may lead to patient infection.
What to do
FDA enforcement status: Terminated
Brands named
bioventus
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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