Recall Z-1737-2013
SpineFrontier, Inc. · initiated December 30, 2011
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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.
Codes / lots: Lot Number: 002876-007R
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.
FDA-determined 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.
Details
- Recall number
- Z-1737-2013
- Initiated
- December 30, 2011
- Posted by FDA
- July 16, 2013
- Terminated
- January 8, 2014
- Product code
- MNI – Orthosis, Spinal Pedicle Fixation
- Quantity
- 2 rods
- Distribution
- USA Nationwide Distribution including the state of TX
- Recalling firm
- SpineFrontier, Inc., Beverly, MA