Recall Z-0207-2013 ยท HSB Rod, Fixation, Intramedullary And Accessories
OrthoPediatrics Corp
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
| Date | Nov 5, 2012 (initiated Sep 13, 2012) |
| Status | Terminated |
| 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. |
| Root cause | 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 | 78 |
| Distribution | Nationwide Distribution including AL, IL, NY, FL, TX, MI, KY, NC, CO, and GA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K024173 | CDS 3-PD HEMATOLOGY CONTROLS Clinical Diagnostic Solutions, Inc., Jan 14, 2003 |