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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 83984

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

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Event summary

Timeline bucket
August 15, 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 Olecranon Hook Plate, Lt, 6-Holes, REF: OHOOKL-6, Non-Sterile, RX only, (01) 00842188101281 - Product Usage: The OHOOKL is a semi-tubular design bone plate with two offset intramedullary tines, which are intended to penetrate the small terminal fragment to provide additional stabilization.

Z-0366-2020
Recall number
Z-0366-2020
Initiated
August 15, 2018
Classification
Class II
Status
Terminated
Recalling firm
TriMed Inc.
Quantity
583 Bone Plates

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm has become aware that the angled-hole of certain semi-tubular design bone plates may have been modified from its specification, and the modification may not have been fully qualified.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The firm has become aware that the angled-hole of certain semi-tubular design bone plates may have been modified from its specification, and the modification may not have been fully qualified.

Code information

Lot # 110631,

Distribution pattern

US Nationwide distribution in the states of MD, UT.