Magnifuse Bone Graft, Large, Size: 14mm x 25mm, REF 7509014, Human Tissue, Demineralized Bone Matrix, sterile.
FDA Recall Z-2524-2023 · Posted 2023-09-08
Recalling FirmMedtronic Sofamor Danek USA Inc
Recall StatusOpen, Classified
Product CodeMQV
Date Initiated2023-07-31
Product Quantity55 pouches
Reason for Recall
The incorrect product labeling was applied to the product indicating the wrong size of product.
Firm 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.
Root Cause
Process control
Distribution Pattern
US Nationwide distribution in the states of ID, IN, MN, NC, NY, OH, OR, WA, and WI.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.