Reported Apr 15, 2026 · Ongoing

XTANT MEDICAL Xpress Pedicle Screw System Dual Lead 6.5 x 50 mm, Part Number X073-6555-DL.

XTANT Medical Holdings, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: XTANT Medical Holdings, Inc · 664 Cruiser Ln · Belgrade, MT · 59714-9719

Is this the product you have?

  • XTANT MEDICAL Xpress Pedicle Screw System Dual Lead 6.5 x 50 mm, Part Number X073-6555-DL.
Lot codes and dates
    • UDI/DI M697X0736555DL1
    • Lot Number 4375-01
Amount recalled
2 units

Where it was sold

Why it was recalled

Units from one lot were mislabeled with an incorrect part number, identifying the device as a shorter screw length than it physically is.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 3:38 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.