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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 79224

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

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Event summary

Timeline bucket
January 11, 2018
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
TriMed 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

Hex Driver Part Number HXDRIVER-2.0 AO; Hex Driver Part Number HXDRIVR-2.5 AO; Hex Driver Part Number HXDRIVR-2.5CL AO; Hex Driver Part Number DVHX-2.5/130C AO; Hex Driver Part Number HXDRIVR-3.0 AO; Hex Driver Part Number HXDRIVER-3.5AO

Z-1373-2018
Recall number
Z-1373-2018
Initiated
January 11, 2018
Classification
Class II
Status
Terminated
Recalling firm
TriMed Inc.
Quantity
1525 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Following the completion of sterilization cycle(s) of the impacted Hex Driver, the epoxy color band on the impacted Hex Driver can migrate down the shaft and/or potentially onto the sterilization tray or caddy.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

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Reason for recall

Following the completion of sterilization cycle(s) of the impacted Hex Driver, the epoxy color band on the impacted Hex Driver can migrate down the shaft and/or potentially onto the sterilization tray or caddy.

Code information

Affected lot numbers: 922361, 922362, 91956, 91957, 92237, 92238, 91858, 92235, 92656, 91856, 91857

Distribution pattern

US, China, Latin America