FDA Device recall Z-2524-2023
Magnifuse Bone Graft, Large, Size: 14mm x 25mm, REF 7509014, Human Tissue, Demineralized Bone Matrix, sterile
- FDA Device
- Class II
- ongoing
- Published 2023-09-20
On 2023-09-20 the FDA classified a Class II recall of Magnifuse Bone Graft, Large, Size: 14mm x 25mm, REF 7509014, Human Tissue, Demineralized Bone Matrix, sterile by Medtronic Sofamor Danek Usa, citing the incorrect product labeling was applied to the product indicating the wrong size of product.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2524-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-07-31 |
| Published | 2023-09-20 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Medtronic Sofamor Danek Usa |
| Distribution | US |
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.
Identifiers
| code_info | Serial numbers: A57958-011, A57958-012, A57958-013, A57958-014, A57958-015, A57958-016, A57958-017, A57958-018, A579…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2524-2023%22
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