FDA-Device2013-07-24Class II
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.
SpineFrontier, Inc.
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.
Sold states
USA Nationwide Distribution including the state of TX
Affected count
2 rods
Manufactured in
500 Cummings Ctr Ste 3500, N/A, Beverly, MA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1737-2013Don't want to check this manually?
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