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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 83884

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

Open FDA event record

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

2 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 2

Model No. 01-1501-0032 (Child Nail Attachment Bolt). Component of the Pediatric Nailing Platform. Product Usage: an orthopedic implant system commonly referred to as an intramedullary fixation rod (product code HSB). The attachment bolts are one component of the surgical instruments within the system.

Z-0218-2020
Recall number
Z-0218-2020
Initiated
August 19, 2019
Classification
Class II
Status
Terminated
Recalling firm
OrthoPediatrics Corp
Quantity
969 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Binding can occur between the attachment bolt and intramedullary nail, which may lead to delays in surgical procedures.

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

Binding can occur between the attachment bolt and intramedullary nail, which may lead to delays in surgical procedures.

Code information

173265-A 175220-A 177576-A 183279-A 187374-A 192277-A 192277-B 192431-A 192431-B

Distribution pattern

Worldwide distributions - US Nationwide distributions including states of AL, AZ, CA, CO, FL, GA, IA, IL, IN, KY, MD, MI, NC, NY, OH, OK, TN, TX, UT, VA, WA, and WI. Country of Australia.

device · product 2 of 2

Model No. 01-1503-0032 (Adolescent Nail Attachment Bolt). Component of the Pediatric Nailing Platform. Product Usage: an orthopedic implant system commonly referred to as an intramedullary fixation rod (product code HSB). The attachment bolts are one component of the surgical instruments within the system.

Z-0219-2020
Recall number
Z-0219-2020
Initiated
August 19, 2019
Classification
Class II
Status
Terminated
Recalling firm
OrthoPediatrics Corp
Quantity
969 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Binding can occur between the attachment bolt and intramedullary nail, which may lead to delays in surgical procedures.

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

Binding can occur between the attachment bolt and intramedullary nail, which may lead to delays in surgical procedures.

Code information

175221-A 177577-A 183280-A 187375-A 189808-A 192279-B 192432-B 198082-C

Distribution pattern

Worldwide distributions - US Nationwide distributions including states of AL, AZ, CA, CO, FL, GA, IA, IL, IN, KY, MD, MI, NC, NY, OH, OK, TN, TX, UT, VA, WA, and WI. Country of Australia.