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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 93296

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

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Event summary

Timeline bucket
September 22, 2023
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Musculoskeletal Transplant Foundation, 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

DBX Demineralized Bone Matrix Putty 10cc-Indicated for treatment of surgically created osseous defects or osseous defects created from traumatic injury. Model Number: 038100

Z-0323-2024
Recall number
Z-0323-2024
Initiated
September 22, 2023
Classification
Class II
Status
Ongoing
Quantity
18 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Units are labeled as 10cc; however the units have a fill volume of 1cc units. This may result in prolongation of surgery.

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

Units are labeled as 10cc; however the units have a fill volume of 1cc units. This may result in prolongation of surgery.

Code information

GUID: W4184038100T0473 Serial #s: 002220854711400006 002220854711400056 002220854711400003 002220854711400008 002220854711400009 002220854711400001 002220854711400002 002220854711400010 002220854711400011 002220854711400012 002220854711400013 002220854711400014 002220854711400004 002220854711400005 002220854711400007 Exp.Date: June 20, 2025

Distribution pattern

US Nationwide distribution in the states of PA, TX, WA.