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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 67194

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

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Event summary

Timeline bucket
October 03, 2013
Product types
Device
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Biomet 3i, LLC

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

ENDOBON XENOGRAFT GRANULES 0.5 ML (Bovine bone substitute) Endobon is a bone substitute of bovine origin formed from ceramised bone for implantation or transplantation when bone is lost due to trauma or requested during reconstructive surgery.

Z-1233-2014
Recall number
Z-1233-2014
Initiated
October 03, 2013
Classification
Class III
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
704

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
label with the wrong

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Error in labeling

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Individual pieces of a batch of Biomet's Endobon Xenograft Granules 0.5 ML (Bovine Bone substitute) may have an incorrect label with the wrong batch number.

Code information

Model # ROX05, Batch # S0171051

Distribution pattern

Worldwide Distribution - USA including CA, DC, FL, LA, MA, MO, NC, NJ, NY, TX, VA, WA and Hawaii and Internatially to Austria, Belgium, Canada, Switzerland, Germany, Spain, France, Great Britain (UK), Ireland, Mexico, Poland, Portugal, and Singapore.