Recall Z-1148-2019 ยท MQV Filler, Bone Void, Calcium Compound
Bioventus, LLC
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.
| Date | Feb 13, 2019 |
| Status | Terminated |
| 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. |
| Root cause | Package design/selection |
| 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: Notice2019-02@bioventusglobal.com a. Bioventus will email a Return Authorization number and Shipping Return Label after receiving the |
| Quantity | 10,793 |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K132071 | BIOACTIVE BONE GRAFT PUTTY Biostructures, LLC, Jan 10, 2014 |