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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 72552

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

Open FDA event record

Event summary

Timeline bucket
October 26, 2015
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Astora

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

MiniArc Pro Single incision Sling System, Model number / Product Reference 9000261, Lot 936405xxx. Designed to treat female stress urinary incontinence.

Z-0279-2016
Recall number
Z-0279-2016
Initiated
October 26, 2015
Classification
Class II
Status
Terminated
Recalling firm
Astora
Quantity
52

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The lot number on the outer carton label did not match the lot number printed on the tray label or identification labels inside the box. The identification labels inside the box are placed on medical records and other documents associated with the procedure. Use of incorrectly identified labels may prevent direct traceability of the implanted unit in the future.

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 lot number on the outer carton label did not match the lot number printed on the tray label or identification labels inside the box. The identification labels inside the box are placed on medical records and other documents associated with the procedure. Use of incorrectly identified labels may prevent direct traceability of the implanted unit in the future.

Code information

Lot number 936405. Serial numbers 936405001 through 936405056

Distribution pattern

Distributed in the states of AZ, CA, DE, IL, KS, NE, NJ, NY, OH, PA, TX