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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 83563

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

Open FDA event record

Event summary

Timeline bucket
August 24, 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

TriMed Dorsal Wrist Hook Plate, Dorsal, 4-Hole, REF WHD-4, contained in a tray, insert, or poly package containing varying amounts, Nonsterile, Single Use Only, Rx. The firm name on the label is TriMed, Santa Clarita, CA.

Z-0118-2020
Recall number
Z-0118-2020
Initiated
August 24, 2018
Classification
Class II
Status
Terminated
Recalling firm
TriMed Inc.
Quantity
5 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Modifications to the specification were not appropriately qualified through the company's design control process which may result in structural integrity issues of the device.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Modifications to the specification were not appropriately qualified through the company's design control process which may result in structural integrity issues of the device.

Code information

Lot numbers 28884, 28885, 28886, and 28887

Distribution pattern

Distribution was made to CA, FL, MD, TX, and WA. There was military and foreign distribution was made to Australia. There was no government distribution.