Exact FDA event identifier

Event 75758

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

Open FDA event record

Event summary

Timeline bucket: November 18, 2016
Product types: Device
Classifications: Class III
Statuses: Terminated
Recalling firm wording: OrthoPediatrics Corp

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

OrthoPediatrics PediNail Intramedullary Nailing System 4.5mm X 48mm Cortical Screw

Z-0879-2017

Recall number: Z-0879-2017
Initiated: November 18, 2016
Classification: Class III
Status: Terminated
Recalling firm: OrthoPediatrics Corp
Quantity: 22 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Labeled as a 48mm Cortical Screw but measuring at 50mm

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling mix-ups

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Labeled as a 48mm Cortical Screw but measuring at 50mm

Code information

Product Number: 10-1500-3048 Lot Number: 161421-G

Distribution pattern

Worldwide Distribution - US Distribution to the states of : TX, MO, FL, GA, NC, AZ, NY., and to the countries of France and Ireland.