Exact FDA event identifier

Event 92390

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

Open FDA event record

Event summary

Timeline bucket: July 23, 2019
Product types: Device
Classifications: Class II
Statuses: Ongoing
Recalling firm wording: New Standard Device 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

'n'-Hole Post which is a component of the Revolution External Fixation System Catalog Numbers: 100801, 100802, 100803, 100804, 100805

Z-1824-2023

Recall number: Z-1824-2023
Initiated: July 23, 2019
Classification: Class II
Status: Ongoing
Recalling firm: New Standard Device Inc
Quantity: 222 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The threads on posts stripping out when tensioned during application process.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The threads on posts stripping out when tensioned during application process.

Code information

Catalog Numbers / Lot Numbers: 100801 / A29318R 100802 / A29318S 100803 / A29318T 100804 / A29318U 100805 / A29318V UDI Codes: Not provided/None

Distribution pattern

U.S. Nationwide distribution in the states of AZ, CT, OH, TX, VA.