Z-2524-2023Class II

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

Name: Z-2524-2023 Magnifuse Bone Graft, Large, Size: 14mm x 25mm, REF 7509014, Human Tissue, Demineralized Bone Matrix, sterile
Creator: Medtronic Sofamor Danek USA Inc
Published: 2023-07-31
License: https://open.fda.gov/license/

Medtronic Sofamor Danek USA Inc / initiated 2023-07-31 / Open, Classified / root cause: manufacturing process

FDA source

Medtronic Sofamor Danek USA Inc began a recall of Magnifuse Bone Graft, Large, Size: 14mm x 25mm, REF 7509014, Human Tissue, Demineralized Bone Matrix, sterile on 2023-07-31. FDA classified it as Class II and gives the reason as "The incorrect product labeling was applied to the product indicating the wrong size of product". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2524-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-07-31
Posted: 2023-09-08
Recalling firm: Medtronic Sofamor Danek USA Inc
Product: Magnifuse Bone Graft, Large, Size: 14mm x 25mm, REF 7509014, Human Tissue, Demineralized Bone Matrix, sterile.
Product code: MQV Filler, Bone Void, Calcium Compound
Reason for recall: The incorrect product labeling was applied to the product indicating the wrong size of product.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Beginning 7/31/2023, In the U.S. Medtronic initiated a Consignee Notification and Customer Confirmation Form via UPS 2-Day delivery to each listed consignee. Consignees were asked to quarantine and return any affected unused product they may have and complete and return the Customer Confirmation Form (i.e. reply form). Additionally, consignees were asked to forward this notification to those who need to be aware within the organization or to any location which the devices have been transferred.
Quantity in commerce: 55 pouches
Distribution: US Nationwide distribution in the states of ID, IN, MN, NC, NY, OH, OR, WA, and WI.
Product codes and lots: 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, A57958- 086. Exp. 2/15/2025. UDI-DI 00613994986467

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2524-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2524-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-09-20	2023-09-08

Product code MQV

K082615Class IIGrafton R II Edbm, Demineralized Bone Matrix Allograft, Resorbable Calcium Salt Bone Void Filler DevicesOsteotech, Inc. / cleared 2008-10-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)