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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 83767

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

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Event summary

Timeline bucket
August 19, 2019
Product types
Device
Classifications
Class II
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 Adolescent attachment bolt used with the Pediatric Nailing Platform (PNP) targeting arm- intended as an orthopedic implant system (bolt is used to attach the targeting arm to the intramedullary fixation rod) Part number: 01-1503-0032

Z-0125-2020
Recall number
Z-0125-2020
Initiated
August 19, 2019
Classification
Class II
Status
Terminated
Recalling firm
OrthoPediatrics Corp
Quantity
211 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Interference can occur between the adolescent attachment bolt and the adolescent nail, cause a delay in surgical procedures

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Interference can occur between the adolescent attachment bolt and the adolescent nail, cause a delay in surgical procedures

Code information

Lot/serial number: 192432-B 192279-B 189808-A 187375-A 177577-A 183280-A 175221-A 174784-A UDI: 00841132149836

Distribution pattern

Nationwide Foreign: Australia