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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 84405

3 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
November 11, 2019
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Nextremity Solutions

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

3 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 3

Stratum MDS Screw 3.5x46mm ST Part Number: STRM-MDS-3546ST

Z-0776-2020
Recall number
Z-0776-2020
Initiated
November 11, 2019
Classification
Class II
Status
Terminated
Recalling firm
Nextremity Solutions
Quantity
87 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Components 2mm shorter than indicated on the package label

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Components 2mm shorter than indicated on the package label

Code information

Lot Number: M1266 UDI: 00817701023159

Distribution pattern

Nationwide

device · product 2 of 3

Stratum MDS Screw 3.5x48mm ST Part Number: STRM-MDS-3548ST

Z-0777-2020
Recall number
Z-0777-2020
Initiated
November 11, 2019
Classification
Class II
Status
Terminated
Recalling firm
Nextremity Solutions
Quantity
86 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Components 2mm shorter than indicated on the package label

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Components 2mm shorter than indicated on the package label

Code information

Lot Number: M1267 UDI: 00817701023166

Distribution pattern

Nationwide

device · product 3 of 3

Stratum MDS Screw 3.5x50mm ST Part Number: STRM-MDS-3550ST

Z-0778-2020
Recall number
Z-0778-2020
Initiated
November 11, 2019
Classification
Class II
Status
Terminated
Recalling firm
Nextremity Solutions
Quantity
86 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Components 2mm shorter than indicated on the package label

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Components 2mm shorter than indicated on the package label

Code information

Lot Number: M1268 UDI: 00817701023173

Distribution pattern

Nationwide