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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 76842

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

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Event summary

Timeline bucket
April 12, 2017
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
XTANT MEDICAL 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

5.5mm Diameter x 500mm CoCr Straight Rod, Model number X077-0420. The product is packaged in plastic bags with one piece per bag. Product Usage: The 5.5mm dia. X 500 mm CoCr Straight Rod is an accessory to the Fortex Pedicle Screw System. It is a straight rod connected between two or more pedicle screws to create a pedicle screw construct. Indications for Use: The Fortex Pedicle Screw System is indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. In addition, the system is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

Z-1884-2017
Recall number
Z-1884-2017
Initiated
April 12, 2017
Classification
Class II
Status
Terminated
Recalling firm
XTANT MEDICAL INC
Quantity
97 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The material type on the label may incorrectly state Ti6Al-4V ELI. The rods are composed of Cobalt Chromium.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling mix-ups

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The material type on the label may incorrectly state Ti6Al-4V ELI. The rods are composed of Cobalt Chromium.

Code information

Part number X077-0420, lot number 041218

Distribution pattern

Worldwide distribution - US Nationwide in the states of: AZ, CA, CT, GA, LA, NV, OH, TX and in the country of Mexico.