Exact FDA event identifier

Event 85414

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

Open FDA event record

Event summary

Timeline bucket: March 26, 2020
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Medtronic Sofamor Danek USA 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

VERTEX SELECT MULTI AXIAL SCREW. 4.0 X 38MM MULTI AXIAL SCREW. Lot H5517628

Z-1941-2020

Recall number: Z-1941-2020
Initiated: March 26, 2020
Classification: Class II
Status: Terminated
Recalling firm: Medtronic Sofamor Danek USA Inc
Quantity: 83 units.

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Nonconforming product; length of the product measured shorter than the labeled length.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Nonconforming product; length of the product measured shorter than the labeled length.

Code information

Product no. 6958838. UDI: 00613994354686.

Distribution pattern

US Nationwide distribution in the states of CA and MI.