Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
BIOVENTUS Bioactive Bone Graft Putty 15g Rx only/sterile. Filler device Recalled by Bioventus, LLC Due to The firm became aware of the potential for...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Bioventus, LLC directly.
Affected Products
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.
Quantity: 10,793
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed to 29 states: AK, AZ, CA, CO, FL, GA, ID, IL, IN, IA, KS, KY, LA, MD, MA, MI, MO, NE, NV, NJ, NC, OH, OR, TN, TX, UT, WA, WY, DC
About Bioventus, LLC
Bioventus, LLC has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report