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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 66266

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

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Event summary

Timeline bucket
August 28, 2013
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Globus Medical, 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

Globus Medical MicroFuse Putty, 2.5cc and 10cc. Product Usage: MicroFuse Bone Void Filler is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. MicroFuse Bone Void Filleris a bone graft extender to be used with autogenous bone marrow aspirate or autograft

Z-0123-2014
Recall number
Z-0123-2014
Initiated
August 28, 2013
Classification
Class II
Status
Terminated
Recalling firm
Globus Medical, Inc.
Quantity
193

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterility Assurance Level (SAL) of 10(-6) cannot be assured

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 sterility of this product to a Sterility Assurance Level (SAL) of 10(-6) cannot be assured.

Code information

Part number 838.202S (2.5cc), with lot # GBN299BB and expiration date October 2013, and lot #GBN355AB, with expiration date December 2013: and part # 838.210S (10cc) with lot # GBN319AB, with expiration date November 2013, and GBN320BB with expiration date November 2013.

Distribution pattern

USA Nationwide Distribution.

Field note

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