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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 92846

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
July 31, 2023
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Medtronic Sofamor Danek USA Inc

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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

Z-2524-2023
Recall number
Z-2524-2023
Initiated
July 31, 2023
Classification
Class II
Status
Ongoing
Quantity
55 pouches

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
incorrect product labeling

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

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

Distribution pattern

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