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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 62578

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

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Event summary

Timeline bucket
May 31, 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

Low Profile Abutment, Non-Hexed Castable Cylinder Model LPCCC1. Product is labeled in part: "***REF LPCCC1***Low profile Abutment Hexed Castable Cylinder***Cylinder; Cylindre; Zylinder; Cilindro; Cilindro; Cilindro***RX only***NON STERILE***Caution: Law prohibits dispensing without prescription***Consult instructions for use*** Castable cylinders are intended to be used to produce a definitive casting for dental restoration onto which porcelain can then be cast.

Z-2271-2012
Recall number
Z-2271-2012
Initiated
May 31, 2012
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
611 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Biomet 3i conducted a recall on the device Low Profile Abutment, Non-Hexed Castable Cylinder due to some packages labeled LPCCC1, Hexed Castable Cylinder possibly containing LPCCC2, Non-Hexed Castable Cylinders.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling mix-ups

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Inspect official wording and provenance

Reason for recall

Biomet 3i conducted a recall on the device Low Profile Abutment, Non-Hexed Castable Cylinder due to some packages labeled LPCCC1, Hexed Castable Cylinder possibly containing LPCCC2, Non-Hexed Castable Cylinders.

Code information

Lots: 2010100001, 2010080684, and 2010090191

Distribution pattern

Worldwide Distribution-Distributed in the USA and the countries to Spain, France, Germany, Switzerland, and Australia.