Recall Z-2524-2023 ยท MQV Filler, Bone Void, Calcium Compound
Medtronic Sofamor Danek USA Inc
Magnifuse Bone Graft, Large, Size: 14mm x 25mm, REF 7509014, Human Tissue, Demineralized Bone Matrix, sterile.
| Date | Sep 8, 2023 (initiated Jul 31, 2023) |
| Status | Open, Classified |
| Reason | The incorrect product labeling was applied to the product indicating the wrong size of product. |
| Root cause | Process control |
| Action | Beginning 7/31/2023, In the U.S. Medtronic initiated a Consignee Notification and Customer Confirmation Form via UPS 2-Day delivery to each listed consignee. Consignees were asked to quarantine and return any affected unused product they may have and complete and return the Customer Confirmation Form (i.e. reply form). Additionally, consignees were asked to forward this notification to those who need to be aware within the organization or to any location which the devices have been transferred. |
| Quantity | 55 pouches |
| Distribution | US Nationwide distribution in the states of ID, IN, MN, NC, NY, OH, OR, WA, and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K082615 | GRAFTON R II EDBM, DEMINERALIZED BONE MATRIX ALLOGRAFT, RESORBABLE CALCIUM SALT BONE VOID FILLER DEVICES Osteotech, Inc., Oct 16, 2008 |