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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 64989

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
December 30, 2011
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
SpineFrontier, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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.

Z-1737-2013
Recall number
Z-1737-2013
Initiated
December 30, 2011
Classification
Class II
Status
Terminated
Recalling firm
SpineFrontier, Inc.
Quantity
2 rods

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

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Inspect official wording and provenance

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.

Code information

Lot Number: 002876-007R

Distribution pattern

USA Nationwide Distribution including the state of TX