BEUDAMED
    FDA Recall Terminated

    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.

    Recall: Z-1148-2019 · Initiated February 13, 2019

    Recall

    Recall Number
    Z-1148-2019
    Event Number
    82294
    Firm
    Bioventus, LLC
    FEI Number
    3027669735
    Product Code
    MQV
    Status
    Terminated
    Root Cause
    Package design/selection
    Initiated
    February 13, 2019
    Terminated
    November 2, 2020
    Address
    1900 Charles Bryan Rd, Ste 275, Cordova, TN, 38016-5285

    Description

    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.

    Reason

    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.

    Action

    On February 13, 2019, Bioventus sent URGENT: MEDICAL DEVICE RECALL Notification letters to their consignees requesting them to: Actions required by you: 1. Locate any unused products in affected part number and quarantine them immediately. 2. Carry out a physical count of all affected product in your possession and record this data on the Inventory Return Certification Form below. 3. Scan and email a copy of the completed Inventory Return Certification Form to: [email protected] a. Bioventus will email a Return Authorization number and Shipping Return Label after receiving the scanned Inventory Return Certification Form. 4. Return the recalled product along with the completed Inventory Return Certification Form using the provided Shipping Return Label. 5. Important: If you have distributed affected product further, please provide a copy of this Notification to these customers. 6. If you have additional questions, or to order replacement product in alternative sizes, please call Bioventus at (800) 637-4391.

    Distribution

    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.

    Quantity

    10,793