FDAFDA · Food and drugs·Recall number Z-1737-2013
KRD1 PedFuse Rods, Model: IM80100-13 Rev B Product Usage: Pedicle rods are cylindrical rods which act as a linking mechanism between pedicle screws. The rod sits with the pedicle screw tulip and they are locked into place with a set screw or locking cap. The rod may be placed along several pedicle screws. Component rods are used during implantation of pedicle screw system devices intended to provide immobilization and stabilization of spinal segments of skeletally mature patients.
Published July 24, 2013 · Recall initiated: December 30, 2011
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
One of the rods in each of two test constructs did not meet fatigue requirement as outlined in ASTM F1717-04 dynamic compression testing 5 million cycles.
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- SpineFrontier, Inc.
- Distributor
- USA Nationwide Distribution including the state of TX
- Lot
- Lot Number: 002876-007R
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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