Exact FDA event identifier

Event 62351

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

Open FDA event record

Event summary

Timeline bucket: June 14, 2012
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 PediLoc Locking Plate System, 4.5mm Contour Locking Compression Femur 8 Hole Plate Right. Used for pediatric patients as indicated for pelvic, small and long bone fractures.

Z-2057-2012

Recall number: Z-2057-2012
Initiated: June 14, 2012
Classification: Class II
Status: Terminated
Recalling firm: OrthoPediatrics Corp
Quantity: 15 devices

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0

incorrectly labeled

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Error in labeling

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The device is a Left 8 hole plate but is incorrectly labeled and etched as a Right device.

Code information

Lot number: 7736703 and part number: 00-1050-4308

Distribution pattern

Worldwide Distribution -- USA, including states of IN, GA, MI, FL, MO, OH, and SC and country of Australia.