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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 63396

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

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Event summary

Timeline bucket
September 13, 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

Trochar Scalpel Instrument (Surgical Punch) OrthoPediatrics intramedullary rods (nails) are generally rod-shaped devices, with screw holes at either end for fixation to bone. This device is intended to be inserted into the medullary canal of the femur for fixation of fractures by aligning and stabilizing the bone fragments. Additional stabilization may be realized by installing transverse screws through holes in the rod. These devices are made of medical grade stainless steel. The OrthoPediatrics PediNail" system is used for pediatric and small stature adult patients as indicated to stabilize fractures of the femoral shaft; subtrochanteric fractures; ipsilateral neck/shaft fractures; prophylactic nailing of impending pathologic fractures; nonunions and malunions; fixation of femurs that have been surgically prepared (osteotomy) for correction of deformity.

Z-0207-2013
Recall number
Z-0207-2013
Initiated
September 13, 2012
Classification
Class II
Status
Terminated
Recalling firm
OrthoPediatrics Corp
Quantity
78

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
A complaint received from sales representative that a replenishment instrument was too short. Upon investigation, it has been determined that the device was not manufactured to design specifications and will not function as intended.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Reprocessing Controls

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Inspect official wording and provenance

Reason for recall

A complaint received from sales representative that a replenishment instrument was too short. Upon investigation, it has been determined that the device was not manufactured to design specifications and will not function as intended.

Code information

Part number: 01-1500-9014 and Lot #'s 1466707 and 1466710

Distribution pattern

Nationwide Distribution including AL, IL, NY, FL, TX, MI, KY, NC, CO, and GA.