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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 72079

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

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Event summary

Timeline bucket
August 27, 2015
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Bien Air Dental SA

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

Contra-Angles CA1:1L EVO 15 Catalog numbers: 1600939-001 and 1600938-001 Used for generally dentistry procedures

Z-2797-2015
Recall number
Z-2797-2015
Initiated
August 27, 2015
Classification
Class II
Status
Terminated
Recalling firm
Bien Air Dental SA
Quantity
112 (U.S.)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Possible loosening of the dental tool, which may lead to potential swallowing of the tool.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

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Inspect official wording and provenance

Reason for recall

Possible loosening of the dental tool, which may lead to potential swallowing of the tool.

Code information

Catalog numbers: 1600939-001 and 1600938-001 Serial numbers concerned: - Ref: 1600939-001: Serial numbers included in the following range: 15B0001 up to 15F0011 - Ref: 1600938-001: Serial numbers included in the following range: 15B0007 up to 15F0027

Distribution pattern

Worldwide Distribution - US distribution to one distributor in FL.