FDA Medical Device Recalls (openFDA)
SpineFrontier, Inc.: 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.
- Recall number
- Z-1737-2013
- Recalling firm
- SpineFrontier, Inc.
- 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.
- Status
- Terminated
- Initiated
- 2011-12-30
- Posted
- 2013-07-16
- Terminated
- 2014-01-08
- Reason
- 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.
- Root cause
- Vendor change control
- Action
- SpineFrontier issued a Recall Notification to the affected distributor via telephone. The distributor was instructed to return the affected product for a replacement product.
- Quantity
- 2 rods
- Distribution
- USA Nationwide Distribution including the state of TX
- Lot, serial or model codes
- Lot Number: 002876-007R
- 510(k) numbers
- ["K092420"]
- PMA numbers
- not on file
- Product code
- MNI
- Firm FEI
- 3005977257
- Firm city
- Beverly
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28