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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 94872

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

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Event summary

Timeline bucket
June 04, 2024
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
SEASPINE ORTHOPEDICS CORPORATION

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

Brand Name: Meridian Angled Awl Fixed Product Name: Angled Awl Fixed Model/Catalog Number: RA2-003015 Product Description: Surgical Awl Component: No

Z-2357-2024
Recall number
Z-2357-2024
Initiated
June 04, 2024
Classification
Class II
Status
Ongoing
Quantity
100 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Insufficient weld around the cap component of the instrument is insufficient to withstand impaction forces.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Insufficient weld around the cap component of the instrument is insufficient to withstand impaction forces.

Code information

Lot Code: UDI 10889981216368 Lot Numbers TT0190H, TT0191H

Distribution pattern

The product was distributed to the following US states: Nevada, Colorado, Texas, Washington, Indiana, Georgia, Michigan, Florida, Pennsylvania, Illinois, Tennessee, Virginia, Missouri, South Dakota, California, Montana, Minnesota, Arizona