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.
This recall has been terminated (originally issued July 16, 2013).
- Company
- Spinefrontier, Inc.
- Recall Initiated
- December 30, 2011
- Posted
- July 16, 2013
- Terminated
- January 8, 2014
- Recall Number
- Z-1737-2013
- Quantity
- 2 rods
- Firm Location
- Beverly, MA
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
USA Nationwide Distribution including the state of TX
Lot / Code Info
Lot Number: 002876-007R
Root Cause
Vendor change control
Action Taken
SpineFrontier issued a Recall Notification to the affected distributor via telephone. The distributor was instructed to return the affected product for a replacement product.
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