Recall Z-2524-2023— Medtronic Sofamor Danek USA Inc

Name: FDA recall Z-2524-2023
Creator: U.S. Food and Drug Administration
Published: 2023-07-31

Class II · Ongoing

Class II FDA medical device recall by Medtronic Sofamor Danek USA Inc, initiated 2023-07-31. It names one FDA 510(k) clearance: K082615. Product: Magnifuse Bone Graft, Large, Size: 14mm x 25mm, REF 7509014, Human Tissue, Demineralized Bone Matrix, sterile.. Reason: The incorrect product labeling was applied to the product indicating the wrong size of product..

Recalling firm: Medtronic Sofamor Danek USA Inc
Classification: Class II
Status: Ongoing
Initiated: 2023-07-31
Firm location: Memphis, TN, United States

510(k) clearances named in this recall

1 on FDA's record

K082615 — GRAFTON R II EDBM, DEMINERALIZED BONE MATRIX ALLOGRAFT, RESORBABLE CALCIUM SALT BONE VOID FILLER DEVICESOsteotech, Inc.·cleared 2008-10-16

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.