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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 69767

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

Open FDA event record

Event summary

Timeline bucket
October 27, 2014
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Straumann USA, 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

Drill set long, drill stop compatible for 4.8mm diameter implant, Article Number 040.447S Endosseous dental implant drill set.

Z-0981-2015
Recall number
Z-0981-2015
Initiated
October 27, 2014
Classification
Class II
Status
Terminated
Recalling firm
Straumann USA, LLC
Quantity
362 pieces

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Drill set may contain incorrect drill.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Drill set may contain incorrect drill.

Code information

Lot Numbers: GY037, HA443, HE874, HL216

Distribution pattern

Nationwide in the following states: AZ, CA, CO,CT, FL, IA, IL, IN, LA, MA, MD, ME, MN, MO, NC, NJ, NY, OH, OK, OR, PA, RI, TX, VA and WV. Worldwide in the following countries by Institut Straumann AG distribution network: Austria, Australia, Canada, Germany, Spain, Finland, France, United Kingdom, Netherlands, Belgium, Switzerland, Ireland, Italy.