Reported Nov 14, 2012 · Terminated
Trochar Scalpel Instrument (Surgical Punch) OrthoPediatrics intramedullary rods (nails) are generally rod-shaped…
OrthoPediatrics Corp.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: OrthoPediatrics Corp · 2850 Frontier Dr · Warsaw, IN · 46582-7001
Is this the product you have?
- 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.
- Lot codes and dates
- Part number01-1500-9014 and Lot #'s 1466707 and 1466710
- Amount recalled
- 78
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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