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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 69379

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

Open FDA event record

Event summary

Timeline bucket
September 19, 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

Straumann Bone Level Tapered Implant 04.1 mm RC, SLActive¿ 8mm, Roxolid¿, Loxim Article Number: 021 .5308 Dental implants are intended for surgical placement in maxillary and/or mandibular arches to provide support for prosthetic restorations in edentulous or partially edentulous patients. Dental implants are for single-stage or two-stage surgery.

Z-0117-2015
Recall number
Z-0117-2015
Initiated
September 19, 2014
Classification
Class II
Status
Terminated
Recalling firm
Straumann USA, LLC
Quantity
6 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Assembled with Narrow Connect (NC) transfer piece instead of Regular Connect (RC)

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Assembled with Narrow Connect (NC) transfer piece instead of Regular Connect (RC)

Code information

Lot number: GY030 Exp. 2019-04

Distribution pattern

US Distribution in states of: FL and MA.