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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 97367

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

Open FDA event record

Event summary

Timeline bucket
July 16, 2025
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
PREMIA SPINE LTD

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

TOPS Inserter, part of the TOPS System Instrument Set used for implantation of the TOPS System. Model Number: 82889.

Z-2516-2025
Recall number
Z-2516-2025
Initiated
July 16, 2025
Classification
Class II
Status
Ongoing
Recalling firm
PREMIA SPINE LTD
Quantity
30 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for missing pins at tip of inserter.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for missing pins at tip of inserter.

Code information

Model Number: 82889. UDI-DI: 07290115932638. Lot Numbers: RS20220546-1, RS20222162-1, RS20171777-1, RS20171884-1, RS0431-13B-1, 20152764-1, RS0431-02-1.

Distribution pattern

US Nationwide distribution in the state of Connecticut.