FDA recall Z-2524-2023

Medtronic Sofamor Danek USA Inc · Class II · device

Product

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

Reason for recall

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

Distribution

US Nationwide distribution in the states of ID, IN, MN, NC, NY, OH, OR, WA, and WI.

Key facts

Status
Ongoing
Initiation date
2023-07-31
Report date
2023-09-20
Voluntary/Mandated
Voluntary: Firm initiated
Location
Memphis, TN, United States

Primary source

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