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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 79274

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

Open FDA event record

Event summary

Timeline bucket
October 23, 2017
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Alto Development Corp

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

Surgical punch; sealed pouches packed in punch shelf box Intended for use by trained surgeons to create circular cuts in soft tissue or openings in soft vessel walls during surgical procedures.

Z-0813-2018
Recall number
Z-0813-2018
Initiated
October 23, 2017
Classification
Class II
Status
Terminated
Recalling firm
Alto Development Corp
Quantity
411,486 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
loss of sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Package design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Surgical punches are being recalled due to potential packaging damage which may have occurred during transportation resulting in loss of sterility.

Code information

080-271 (9108 units); 080-351 (41712 units); 080-401(219954 units); 080-403 (1368 units); 080-451 (83190 units); 080-481 (32556 units); 080-501 (23598 units)

Distribution pattern

Worldwide Distribution - USA Distribution