Z-1737-2013 Class II Terminated
FDA device recall Z-1737-2013 was initiated by SpineFrontier, Inc. on Dec 30, 2011 and is designated Class II. 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. The recall status is terminated (terminated Jan 8, 2014). Affected quantity: 2 rods.
Recall details
- Product Type
- Devices
- Report Date
- Jul 24, 2013
- Initiation Date
- Dec 30, 2011
- Termination Date
- Jan 8, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2 rods
Product description
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.
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 pattern
USA Nationwide Distribution including the state of TX
Code information
Lot Number: 002876-007R
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1737-2013
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026