Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
KRD1 PedFuse Rods Recalled by SpineFrontier, Inc. Due to One of the rods in each of two...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact SpineFrontier, Inc. directly.
Affected 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.
Quantity: 2 rods
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About SpineFrontier, Inc.
SpineFrontier, Inc. has 33 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report