Z-0207-2013 Class II Terminated
FDA device recall Z-0207-2013 was initiated by OrthoPediatrics Corp on Sep 13, 2012 and is designated Class II. 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… The recall status is terminated (terminated Sep 18, 2013). Affected quantity: 78.
Recall Details
- Product Type
- Devices
- Report Date
- Nov 14, 2012
- Initiation Date
- Sep 13, 2012
- Termination Date
- Sep 18, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 78
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.
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.
Distribution Pattern
Nationwide Distribution including AL, IL, NY, FL, TX, MI, KY, NC, CO, and GA.
Code Information
Part number: 01-1500-9014 and Lot #'s 1466707 and 1466710
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0207-2013
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026