Recall Z-0207-2013
OrthoPediatrics Corp · initiated September 13, 2012
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Part number: 01-1500-9014 and Lot #'s 1466707 and 1466710
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.
FDA-determined cause: Reprocessing Controls
Action taken
OrthoPediatrics Corp sent an Urgent Recall e-mail dated September 14, 2012, to all affected customers. The e-mail identified the product, the problem, and the action to be taken by the customer. Customers were instructed to quarantine all identified devices from the affected lot numbers immediately. Customers were also asked to complete the Mandatory Reply Form. Customers with questions should call 574-268-6379.
Details
- Recall number
- Z-0207-2013
- Initiated
- September 13, 2012
- Posted by FDA
- November 5, 2012
- Terminated
- September 18, 2013
- Product code
- HSB – Rod, Fixation, Intramedullary And Accessories
- Quantity
- 78
- Distribution
- Nationwide Distribution including AL, IL, NY, FL, TX, MI, KY, NC, CO, and GA.
- Recalling firm
- OrthoPediatrics Corp, Warsaw, IN