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Terminated

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.

FDA Recall Z-1737-2013 · Posted 2013-07-16

Recalling FirmSpineFrontier, Inc.
Recall StatusTerminated
Product CodeMNI
Date Initiated2011-12-30
Date Terminated2014-01-08
Product Quantity2 rods

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.

Firm 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.

Root Cause

Vendor change control

Distribution Pattern

USA Nationwide Distribution including the state of TX

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K092420KRD1 PEDICLE SCREW SYSTEMSpinefrontier, Inc. · 2009-11-19

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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