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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 72658

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

Open FDA event record

Event summary

Timeline bucket
November 16, 2015
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

Radiographic Transparency for Certain and External Connection Tapered Implants. Images that assist with measurements for dental implants.

Z-0564-2016
Recall number
Z-0564-2016
Initiated
November 16, 2015
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
686

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Images contained within radiographic transparency ART 1036 are undersized.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design (manufacturing process)

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Images contained within radiographic transparency ART 1036 are undersized.

Code information

Model Number: ART 1036, Rev. C 03/13; Purchase Order # 184427.

Distribution pattern

Worldwide Distribution - US Distribution including Puerto Rico., and to the states of : CA, CO, FL, IL, MA, MI, MO, NY, OH, SC, TX, VA, WI, WV and Hawaii., and to the countries of : Australia, Germany, France, Greece, Northern Mariana Islands, Taiwan and Uruguay.