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FDA (Device enforcement)Recalled 2023-07-31class ii

Medtronic Sofamor Danek USA Inc: Magnifuse Bone Graft, Large, Size: 14mm x 25mm, REF 7509014, Human Tissue, Demineralized Bone Matrix, sterile.

Hazard

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

Details from the source

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. Quantity: 55 pouches Lot/code info: 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

UPC codes

00613994986467

Source

Official record: FDA (Device enforcement)

Republished from the official source above; details can change — the source record controls.

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