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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 63313

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

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Event summary

Timeline bucket
August 03, 2012
Product types
Device
Classifications
Class II
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

Osseotite Tapered Certain Implant 5 X 10mm Model INT510 Biomet 3i Dental Implants are intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single teeth utilizing delayed or immediate loading or with a terminal or intermediary abutment for fixed or removable bridgework and to retain over dentures.

Z-0119-2013
Recall number
Z-0119-2013
Initiated
August 03, 2012
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
227

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Biomet 3i recalled their Osseotite Tapered Certain Implant, Model # INT510 due to a small percentage of the devices are missing the internal threading.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

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Inspect official wording and provenance

Reason for recall

Biomet 3i recalled their Osseotite Tapered Certain Implant, Model # INT510 due to a small percentage of the devices are missing the internal threading.

Code information

Model # INT510, Lot # 2011090751

Distribution pattern

Worldwide Distribution - USA including PA, GA, OR, KS, NY, VA, CT, NH, IL, OK, and MA and internationally to Australia, Brazil, Columbia, France, Germany, Ireland, Italy, Japan, Paraguay, Portugal, and Spain.