MAGNIFUSE Bone Graft recallZ-2524-2023 · Medtronic Sofamor Danek USA Inc · initiated Jul 31, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Medtronic Sofamor Danek USA Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The incorrect product labeling was applied to the product indicating the wrong size of product.
FDA root cause category: Process control
What the company is doing
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.
Recall details
- Recall number
- Z-2524-2023
- Status
- Open, Classified
- Initiated by the company
- Jul 31, 2023
- Posted by the FDA
- Sep 8, 2023
- Recalling firm
- Medtronic Sofamor Danek USA Inc
- Quantity
- 55 pouches
- Product code
- MQV
- FDA submissions
- K082615
- Distribution
- US Nationwide distribution in the states of ID, IN, MN, NC, NY, OH, OR, WA, and WI.
Product description
Magnifuse Bone Graft, Large, Size: 14mm x 25mm, REF 7509014, Human Tissue, Demineralized Bone Matrix, sterile.
Code information (models, lots, serial numbers)
Show the full code information (1k characters)
Serial numbers: A57958-011, A57958-012, A57958-013, A57958-014, A57958-015, A57958-016, A57958-017, A57958-018, A57958-019, A57958-020, A57958-021, A57958-022, A57958-023, A57958-024, A57958-025, A57958-026, A57958-027, A57958-028, A57958-029, A57958-030, A57958-031, A57958-033, A57958-034, A57958-035, A57958-036, A57958-037, A57958-038, A57958-048, A57958-050, A57958-051, A57958-052, A57958-053, A57958-054, A57958-055, A57958-056, A57958-057, A57958-058, A57958-059, A57958-060, A57958-066, A57958-069, A57958-070, A57958-072, A57958-073, A57958-074, A57958-075, A57958-076, A57958-077, A57958-078, A57958-079, A57958-080, A57958-081, A57958-082, A57958-085, A57958- 086. Exp. 2/15/2025. UDI-DI 00613994986467
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- MAGNIFUSE® Bone Graft 7509014Medtronic Sofamor Danek, Inc. · FILLER, BONE VOID, CALCIUM COMPOUND1 recall2 reports
Product lines
Other devices under the same FDA submission
2 devices cleared under K082615 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- MAGNIFUSE® Bone Graft 7509145Medtronic Sofamor Danek, Inc. · FILLER, BONE VOID, CALCIUM COMPOUND1 report
- MAGNIFUSE® Bone Graft 7509215Medtronic Sofamor Danek, Inc. · FILLER, BONE VOID, CALCIUM COMPOUND1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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