Z-1737-2013Class II

KRD1 PedFuse Rods, Model: IM80100-13 Rev B

Name: Z-1737-2013 KRD1 PedFuse Rods, Model: IM80100-13 Rev B
Creator: SpineFrontier, Inc.
Published: 2011-12-30
License: https://open.fda.gov/license/

SPINEFRONTIER, Inc. dba LESspine Innovations / initiated 2011-12-30 / Terminated / root cause: supplier

FDA source

SpineFrontier, Inc. began a recall of 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... on 2011-12-30. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as supplier.

Recall record

Recall number: Z-1737-2013
Classification: Class II
Status: Terminated
Initiated: 2011-12-30
Posted: 2013-07-16
Terminated: 2014-01-08
Recalling firm: SPINEFRONTIER, Inc. dba LESspine Innovations
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.
Product code: MNI Orthosis, Spinal Pedicle Fixation
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.
Root cause tag: supplier
FDA 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 in commerce: 2 rods
Distribution: USA Nationwide Distribution including the state of TX
Product codes and lots: Lot Number: 002876-007R

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1737-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1737-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-24	2013-07-16

Product code MNI

K092420Class IIKrd1 Pedicle Screw SystemSpinefrontier, Inc. / cleared 2009-11-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)