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.
The incorrect product labeling was applied to the product indicating the wrong size of product.
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.
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.
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.
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.
Look for the serial numbers listed (A57958-011 to A57958-086) and expiration date of February 15, 2025.
The recall indicates the product was labeled with the wrong size. The correct size is not specified in the recall notice.
Check for serial numbers starting with A57958-011 to A57958-086 and an expiration date of February 15, 2025.
The recall does not specify a remedy, so no action is required if the product was not used in surgery.
We’ve drafted a message you can send Medtronic Sofamor Danek to request your refund or repair — edit it as you like.
Subject: Recall Z-2524-2023 — Medtronic Sofamor Danek Medtronic Sofamor Danek Hello, I own a Medtronic Sofamor Danek that is covered by recall Z-2524-2023 from Medtronic Sofamor Danek. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
