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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 70628

3 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
November 07, 2014
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

3 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 3

3i T3 Non-Platform Switched Tapered Implant Rx Only; 3.25 x 8.5 - 15.0 mm Dental Implants.

Z-1409-2015
Recall number
Z-1409-2015
Initiated
November 07, 2014
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
620 implants in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Endosseous Dental Implants in contact with a residual machine fluid caused the implants to be discolored.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Manufacturing material removal

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Endosseous Dental Implants in contact with a residual machine fluid caused the implants to be discolored.

Code information

Implant PN # BOST3211 Lot # 2014051395 Exp date 12/11/2018 and Lot # 2014051817 Exp date 12/09/2018

Distribution pattern

Worldwide Distribution-US (nationwide) including the states of AL, AZ, CA, CO, CT, DE, FL, GA, IL, KY, LA, MA, MD, MI, NC, NH, NJ, NY, OH, OR, PA, SC, TN, TX, VA, WA and HI and the countries of Austria, Australia, Canada, France, Germany, Italy, Japan, Netherlands, New Zealand, Portugal, Spain, Turkey, Taiwan, and United Kingdom.

device · product 2 of 3

OSSEOTITE Tapered Certain Implant Rx Only; 3.25 x 18.5 - 15.0 mm. Dental Implants.

Z-1410-2015
Recall number
Z-1410-2015
Initiated
November 07, 2014
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
620 implants in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Endosseous Dental Implants in contact with a residual machine fluid caused the implants to be discolored.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Manufacturing material removal

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Endosseous Dental Implants in contact with a residual machine fluid caused the implants to be discolored.

Code information

Implant PN # IFNT3211 Lot # 2014051477 Exp date 12/06/2018

Distribution pattern

Worldwide Distribution-US (nationwide) including the states of AL, AZ, CA, CO, CT, DE, FL, GA, IL, KY, LA, MA, MD, MI, NC, NH, NJ, NY, OH, OR, PA, SC, TN, TX, VA, WA and HI and the countries of Austria, Australia, Canada, France, Germany, Italy, Japan, Netherlands, New Zealand, Portugal, Spain, Turkey, Taiwan, and United Kingdom.

device · product 3 of 3

OSSEOTITE Certain 2 Implant Rx only; 3.25 x 8.5 - 18 mm. Dental Implants.

Z-1411-2015
Recall number
Z-1411-2015
Initiated
November 07, 2014
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
620 implants in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Endosseous Dental Implants in contact with a residual machine fluid caused the implants to be discolored.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Manufacturing material removal

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Endosseous Dental Implants in contact with a residual machine fluid caused the implants to be discolored.

Code information

Implant PN # XIFOSM311 Lot # 2014051368 Exp date 12/03/2018

Distribution pattern

Worldwide Distribution-US (nationwide) including the states of AL, AZ, CA, CO, CT, DE, FL, GA, IL, KY, LA, MA, MD, MI, NC, NH, NJ, NY, OH, OR, PA, SC, TN, TX, VA, WA and HI and the countries of Austria, Australia, Canada, France, Germany, Italy, Japan, Netherlands, New Zealand, Portugal, Spain, Turkey, Taiwan, and United Kingdom.

Field note

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