BIOVENTUS Bioactive Bone Graft Putty Rx only/sterile recalled over sterility concerns

Recall date

February 13, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Bioventus, LLC recalls BIOVENTUS Bioactive Bone Graft Putty 15g Rx only/sterile. Filler device intended for use in bony voids or gaps that are…

Recall number

Z-1148-2019

FDA classification

Class II

Brand / firm

Bioventus, LLC

Sold / distributed

AK, AZ, CA, CO, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MO, NC, NE, NJ, NV, OH, OR, TN, TX, UT, WA, and WY.

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.