KRD1 PedFuse Rods, Model: IM80100-13 Rev B recallZ-1737-2013 · SpineFrontier, Inc. · initiated Dec 30, 2011
Class II Terminated All recalls posted in July 2013
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from SpineFrontier, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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.
FDA root cause category: Vendor change control
What the company is doing
SpineFrontier issued a Recall Notification to the affected distributor via telephone. The distributor was instructed to return the affected product for a replacement product.
Recall details
- Recall number
- Z-1737-2013
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Dec 30, 2011
- Posted by the FDA
- Jul 16, 2013
- Recalling firm
- SpineFrontier, Inc.
- Quantity
- 2 rods
- Product code
- MNI
- FDA submissions
- K092420
- Distribution
- USA Nationwide Distribution including the state of TX
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.
Code information (models, lots, serial numbers)
Lot Number: 002876-007R
Other devices under the same FDA submission
1 device cleared under K092420 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- PedFuse® 01-80101Spinefrontier, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION3 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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