The Recall Desk
HighFDA (Devices)·Z-1737-2013·Announced 2013-07-24

SpineFrontier Recalls KRD1 PedFuse Rods Due to Fatigue Testing Failures

SpineFrontier, Inc. is recalling KRD1 PedFuse Rods because one rod in each of two test constructs failed to meet fatigue requirements during dynamic compression testing.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device that failed structural fatigue testing, representing a risk of harm where injury has not yet been reported, which aligns with the 'High' severity criteria for risk-of-harm products.

Plain-English summary

SpineFrontier, Inc. is recalling KRD1 PedFuse Rods, Model IM80100-13 Rev B. The recalled product consists of 2 rods from Lot Number 002876-007R. These pedicle rods are used as a linking mechanism between pedicle screws to provide immobilization and stabilization of spinal segments in skeletally mature patients.

The recall was initiated because one of the rods in each of two test constructs did not meet the fatigue requirement outlined in ASTM F1717-04 dynamic compression testing for 5 million cycles. This indicates a potential failure in the structural integrity of the device under specific testing conditions.

The affected products were distributed nationwide in the United States, including the state of Texas. Consumers and healthcare providers should stop using the recalled rods and contact SpineFrontier, Inc. for further instructions or a replacement.

The recalled product

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 place
Manufacturer
SpineFrontier, Inc.
Category
Medical Device — Orthopedic Implant
Hazard
Affected units
2

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot Number: 002876-007R

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Related recalls

Same manufacturer · SpineFrontier, Inc.

See all →

Same hazard · structural failure

See all →