FDA-Device2023-09-20Class II

Magnifuse Bone Graft, Large, Size: 14mm x 25mm, REF 7509014, Human Tissue, Demineralized Bone Matrix, sterile.

Medtronic Sofamor Danek USA Inc
Hazard

The incorrect product labeling was applied to the product indicating the wrong size of product.

Sold states
US Nationwide distribution in the states of ID, IN, MN, NC, NY, OH, OR, WA, and WI.
Affected count
55 pouches
Manufactured in
1800 Pyramid Pl, Memphis, TN, United States
Products
Magnifuse Bone Graft, Large, Size: 14mm x 25mm, REF 7509014, Human Tissue, Demineralized Bone Matrix, sterile.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2524-2023

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