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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 63551

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

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Event summary

Timeline bucket
September 18, 2012
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Instratek, Incorporated

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

Endotrig Trigger Release Sterile Micro Hook Blade Product Usage: The blade is intended to release A-1 pulley in endoscopic trigger release procedures.

Z-0922-2013
Recall number
Z-0922-2013
Initiated
September 18, 2012
Classification
Class II
Status
Terminated
Recalling firm
Instratek, Incorporated
Quantity
235

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Instratek, Inc.has received multiple complaints of the 1052 Trigger Finger Release Blades which could not be advanced into the cannula through which it is used during trigger finger release procedures.

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

Instratek, Inc.has received multiple complaints of the 1052 Trigger Finger Release Blades which could not be advanced into the cannula through which it is used during trigger finger release procedures.

Code information

Model number 1052; Lots M674180, MAKL170, M674200

Distribution pattern

USA Nationwide Distribution including the states of: AZ, MI, NE, NV, and TX.