OrthoPediatrics Corp: Medical Device Recall in 2012 - (Recall #: Z-0207-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: September 13, 2012

Date Posted: November 14, 2012

Recall Number: Z-0207-2013

Event ID: 63396

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.

Status: Terminated

Product Quantity: 78

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.

Voluntary or Mandated:

Voluntary: Firm initiated