Magnifuse Bone Graft, Large, Size: 14mm x 25mm, REF 7509014, Human Tissue, Demineralized Bone Matrix, sterile.
FDA device recall Z-2524-2023 · posted 2023-09-08 · Open, Classified
Recall details
- Recalling firm
- Medtronic Sofamor Danek USA Inc
- Reason for recall
- The incorrect product labeling was applied to the product indicating the wrong size of product.
- Action taken
- 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
- Status
- Open, Classified
- Product code
- MQV
- Quantity affected
- 55 pouches
- Distribution
- US Nationwide distribution in the states of ID, IN, MN, NC, NY, OH, OR, WA, and WI.
- Date initiated
- 2023-07-31
- Date posted
- 2023-09-08
- Location
- Memphis, TN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GRAFTON R II EDBM, DEMINERALIZED BONE MATRIX ALLOGRAFT, RESORBABLE CALCIUM SALT BONE VOID FILLER DEVICES (K082615) | Osteotech, Inc. | 2008-10-16 |