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U.S. Department of Health and Human Services

Class 2 Device Recall Trochar Scalpel Instrument (Surgical Punch)

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 Class 2 Recall
Trochar Scalpel Instrument (Surgical Punch)
see related information
Date Posted November 05, 2012
Recall Status1 Terminated on September 18, 2013
Recall Number Z-0207-2013
Recall Event ID 63396
Premarket Notification
510(K) Number
K083726 
Product Classification Rod, Fixation, Intramedullary And Accessories - Product Code HSB
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.
Code Information Part number: 01-1500-9014 and Lot #'s 1466707 and 1466710
Recalling Firm/
Manufacturer
OrthoPediatrics Corp
2850 Frontier Dr
Warsaw, Indiana 46582-7001
For Additional Information Contact Greg Teghtmeyer
574-268-6379
Manufacturer 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 2
PRODUCTION CONTROLS: Reprocessing Controls
Action 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.
Quantity in Commerce 78
Distribution Nationwide Distribution including AL, IL, NY, FL, TX, MI, KY, NC, CO, and GA.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = HSB and Original Applicant = ORTHOPEDIATRICS, CORP.
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