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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 74079

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

Open FDA event record

Event summary

Timeline bucket
March 11, 2016
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Integra York PA, Inc

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

Miltex Premium Grade Self-Lock Chisel Blade Handle, Catalogue No. 4-405, manual surgical instrument.

Z-1841-2016
Recall number
Z-1841-2016
Initiated
March 11, 2016
Classification
Class II
Status
Terminated
Recalling firm
Integra York PA, Inc
Quantity
678 Chisel Blade Holders

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
One lot of self-lock chisel blade handles have a wider slot that holds the chisel blade that may result in the inability to firmly secure the blade in the handle.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

One lot of self-lock chisel blade handles have a wider slot that holds the chisel blade that may result in the inability to firmly secure the blade in the handle.

Code information

Catalogue No. 4-405, Lot # 97327

Distribution pattern

Worldwide distribution. US nationwide, Mexico, and Korea.

Field note

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