Go Backs
HomeCategoriesStatesCheck Your Home
Go Backs

Track product recalls and safety alerts from CPSC, FDA, NHTSA, and USDA. Stay informed and keep your family safe.

Browse

  • Categories
  • States
  • Check Your Home
  • Risk Levels

Agencies

  • CPSC
  • FDA Food
  • FDA Drug
  • FDA Device
  • FDA Veterinary
  • NHTSA
  • USDA

Company

  • About
  • FAQ
  • Contact
  • Terms of Service
  • Privacy Policy

Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

ยฉ 2026 Go Backs. All rights reserved.

Medium RiskFDA Device
Medical Devices/Surgical Equipment

Medtronic Sofamor Danek USA Inc: Magnifuse Bone Graft Recalled for Incorrect Product Size Labeling

Agency Publication Date: September 8, 2023
Share:
Sign in to monitor this recall

Summary

Medtronic Sofamor Danek USA Inc. is recalling 55 pouches of Magnifuse Bone Graft (Large, 14mm x 25mm) because the packaging labels indicate the wrong product size. Using a bone graft of an unintended size during a surgical procedure could lead to surgical delays or improper fit for the patient's clinical needs. These human tissue products were distributed across nine states with expiration dates through February 2025.

Risk

Incorrect size labeling can cause a surgeon to select the wrong product for a procedure, potentially leading to a mismatch between the graft and the surgical site, surgical complications, or the need for additional procedures to correct the issue.

What You Should Do

  1. Check your medical inventory for Magnifuse Bone Graft, Large, Size: 14mm x 25mm (Reference Number 7509014) with UDI-DI 00613994986467.
  2. Verify if your product matches one of the following 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, or A57958-086.
  3. If you have an affected product, immediately quarantine it and contact your healthcare provider or Medtronic Sofamor Danek USA Inc. for further instructions on returning the product.
  4. Medical professionals should review their surgical stock to ensure no mislabeled units are available for use in upcoming procedures.
  5. For additional questions, contact the FDA hotline at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Healthcare provider or manufacturer coordination

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Magnifuse Bone Graft, Large, Size: 14mm x 25mm
Model / REF:
REF 7509014
UDI-DI 00613994986467
Lot Numbers (55):
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
Date Ranges: Exp. 2/15/2025

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 92846
Status: Active
Manufacturer: Medtronic Sofamor Danek USA Inc
Sold By: Hospitals; Surgical centers; Medical distributors
Manufactured In: United States
Units Affected: 55 pouches
Distributed To: Idaho, Indiana, Minnesota, North Carolina, New York, Ohio, Oregon, Washington, Wisconsin

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.