CLASS II ONGOING Device recall · Reported 20 Sep 2023 · FDA Enforcement Report

Magnifuse Bone Graft, Large, Size recalled

Medtronic Sofamor Danek USA is recalling Magnifuse Bone Graft, Large, Size, distributed nationwide in the US. The recall was initiated on 31 Jul 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial 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

Quantity recalled55 pouches

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2524-2023
FDA event ID: 92846
Recalling firm: Medtronic Sofamor Danek USA, Memphis, TN
Classification: Class II
Status: Ongoing
Recall initiated: 31 Jul 2023
FDA classified: 8 Sep 2023
Reported: 20 Sep 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Other Medical Devices

Timeline

31 Jul 2023	Recall initiated by company
8 Sep 2023	Classified by FDA	+39 days
20 Sep 2023	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

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

Where it was distributed

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

Nationwide Indiana Minnesota North Carolina New York Ohio Oregon Washington Wisconsin

Questions about this recall

Why was it recalled?

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

Which lots are affected?

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

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Medtronic Sofamor Danek USA

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1 Nov 2023Device	CLASS II	Grafton DBM Crunch recalled by Medtronic Sofamor Danek USA	Medtronic Sofamor Danek USA	Processing Deviation	TN
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