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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 72368

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

Open FDA event record

Event summary

Timeline bucket
August 10, 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

2 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 2

Biomet 3i Narrow Right Angle Large Driver Tip (Hexed). Driver tips are attached to a surgical drilling unit to carry components such as implant mounts, healing abutments and screws for placement and removal. For dental and restorative procedures.

Z-0266-2016
Recall number
Z-0266-2016
Initiated
August 10, 2015
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
96 pieces

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The RASH3N, a hexed, abutment screw driver tip has been labeled and distributed as RASQ3N, a square, abutment screw driver tip. Additionally, the RASQ3N received the RASH3N's laser marking "RASH3N" during manufacturing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling mix-ups

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The RASH3N, a hexed, abutment screw driver tip has been labeled and distributed as RASQ3N, a square, abutment screw driver tip. Additionally, the RASQ3N received the RASH3N's laser marking "RASH3N" during manufacturing.

Code information

Model # RASH3N Lot # 1184555

Distribution pattern

AK, AZ, CA, CO, CT, FL, GA, IA, ID, IL, KY, LA, MA, MD, MI, MS, NC, NE, NJ, NY, OH, OR, PA, SD, TN, TX, UT, VA, WA, and District of Columbia Argentina, Australia, Belgium, Canada, Colombia, Greece, Hong Kong, Ireland, Italy, South Korea, and Kuwait.

device · product 2 of 2

Biomet 3i Narrow Right Angle Square Driver Tip. Driver tips are attached to a surgical drilling unit to carry components such as implant mounts, healing abutments and screws for placement and removal. For dental and restorative procedures.

Z-0267-2016
Recall number
Z-0267-2016
Initiated
August 10, 2015
Classification
Class II
Status
Terminated
Recalling firm
Biomet 3i, LLC
Quantity
103 pieces

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
RASQ3N, a square, abutment screw driver tip has been labeled and distributed as RASH3N, a hexed, abutment screw driver tip. Additionally, the RASQ3N received the RASH3N's laser marking "RASH3N" during manufacturing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling mix-ups

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

RASQ3N, a square, abutment screw driver tip has been labeled and distributed as RASH3N, a hexed, abutment screw driver tip. Additionally, the RASQ3N received the RASH3N's laser marking "RASH3N" during manufacturing.

Code information

Model # RASQ3N Lot # 1184554

Distribution pattern

AK, AZ, CA, CO, CT, FL, GA, IA, ID, IL, KY, LA, MA, MD, MI, MS, NC, NE, NJ, NY, OH, OR, PA, SD, TN, TX, UT, VA, WA, and District of Columbia Argentina, Australia, Belgium, Canada, Colombia, Greece, Hong Kong, Ireland, Italy, South Korea, and Kuwait.