Medtronic Sofamor Danek Magnifuse Bone Graft Recall: Incorrect Labeling Risk
Medtronic Sofamor Danek recalls Magnifuse Bone Graft (14mm x 25mm) due to incorrect labeling indicating wrong size. Affected units have specific serial numbers and expiration date 2/15/2025.
Lower-risk recall
The incorrect product labeling was applied to the product indicating the wrong size of product.
Contact the company
What happened, in plain English
Medtronic Sofamor Danek is recalling Magnifuse Bone Graft products that were incorrectly labeled with the wrong size. This could lead to improper use during medical procedures if the wrong product is used. Read more at govinfonow.com/recall/57562-medtronic-sofamor-danek-magnifuse-bone-graft-recall-incorrect-labeling-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/57562-medtronic-sofamor-danek-magnifuse-bone-graft-recall-incorrect-labeling-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2524-2023
Cite this page
“Medtronic Sofamor Danek Magnifuse Bone Graft Recall: Incorrect Labeling Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/57562-medtronic-sofamor-danek-magnifuse-bone-graft-recall-incorrect-labeling-risk. Based on FDA recall #Z-2524-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2524-2023%22&limit=1).
Why it’s dangerous
The product was labeled with the wrong size, which could cause improper use during surgery. Using the incorrect size might lead to complications if the wrong product is implanted.
Who’s affected
Patients who received the recalled Magnifuse Bone Graft (14mm x 25mm) during surgery are most at risk. Healthcare providers using the product for medical procedures may also be affected.
How to tell if you have this one
Check for serial numbers starting with A57958-011 to A57958-086. The product expires on February 15, 2025, and has a UDI-DI code of 00613994986467.
- Brand
Medtronic Sofamor Danek- Category
Medical device
What to do — step by step
Check Product Label
Look for the serial numbers listed (A57958-011 to A57958-086) and expiration date of February 15, 2025.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 9 states.
FDA distribution: “US Nationwide distribution in the states of ID, IN, MN, NC, NY, OH, OR, WA, and WI.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Idaho, Indiana, Minnesota, New York, North Carolina, Ohio, Oregon, Washington, Wisconsin.
Recall timeline
FDA published this recall 51 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-2524-2023 (July 31, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2524-2023 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.