Recall Z-0207-2013— OrthoPediatrics Corp

Name: FDA recall Z-0207-2013
Creator: U.S. Food and Drug Administration
Published: 2012-09-13

Class II · Terminated

Class II FDA medical device recall by OrthoPediatrics Corp, initiated 2012-09-13, terminated 2013-09-18. It names one FDA 510(k) clearance: K024173. Product: 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.. Reason: 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..

Recalling firm: OrthoPediatrics Corp
Classification: Class II
Status: Terminated
Initiated: 2012-09-13
Terminated: 2013-09-18
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K024173 — CDS 3-PD HEMATOLOGY CONTROLSClinical Diagnostic Solutions, Inc.·cleared 2003-01-14

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.