Date Initiated by Firm |
September 13, 2012 |
Date Posted |
November 05, 2012 |
Recall Status1 |
Terminated 3 on September 18, 2013 |
Recall Number |
Z-0207-2013 |
Recall Event ID |
63396 |
510(K)Number |
K024173
|
Product Classification |
Mixture, hematology quality control - 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 IN 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 |
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
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database |
510(K)s with Product Code = HSB and Original Applicant = CLINICAL DIAGNOSTIC SOLUTIONS, INC.
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