Enforcement Report - Week of November 14, 2012
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Product Detail
| Product Description | 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. |
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| Recall Number | Z-0207-2013 |
| Classification | Class II |
| Code Info | Part number: 01-1500-9014 and Lot #'s 1466707 and 1466710 |
| Product Distributed Qty | 27 |
| 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. |
Event Detail
| Event Id | 63396 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | OrthoPediatrics Corp |
| City | Warsaw |
| State | IN | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-09-13 |
| Initial Firm Notification of Consignee or Public | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
| Distribution Pattern | Nationwide Distribution including AL, IL, NY, FL, TX, MI, KY, NC, CO, and GA. |
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