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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 95981

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

Open FDA event record

Event summary

Timeline bucket
November 27, 2024
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
IsoTis OrthoBiologics, 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

OsteoSurge 100 Demineralized Bone Matrix Putty with Accell Bone Matrix, OsteoSurge 100 Demineralized Bone Matrix, 10cc, REF 56300100.

Z-0955-2025
Recall number
Z-0955-2025
Initiated
November 27, 2024
Classification
Class II
Status
Ongoing
Quantity
22

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Incorrect expiration date listed on the outer box, which does not align with the correct expiration date listed on the inner tray.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling Change Control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Incorrect expiration date listed on the outer box, which does not align with the correct expiration date listed on the inner tray.

Code information

UDI-DI: 10889981055820, Lot 1031907, Exp. 2025-11-28 (Inner Tray Exp. 2024-11-28) and Lot 1031825, Exp. 2025-07-28 (Inner tray Exp. 2025-03-28)

Distribution pattern

US Nationwide distribution in the states of IN, TN & TX.