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XTANT MEDICAL Xpress Pedicle Screw Recall

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

Updated February 18, 2026

XTANT MEDICAL Xpress Pedicle Screw System units (Part Number X073-6555-DL, 6.5 x 50 mm) from one lot were mislabeled with an incorrect part number, making the actual screw length unclear and creating a risk of surgical placement errors. This could lead to improper spinal alignment or fusion failure.

Is the XTANT Medical Holdings, Inc recalled? Yes. This product was recalled by FDA on February 18, 2026. Details below.

What is recalled

XTANT MEDICAL Xpress Pedicle Screw System Dual Lead 6.5 x 50 mm, Part Number X073-6555-DL. Affected units are from one specific lot and are mislabeled with an incorrect part number that identifies them as a shorter screw length than they actually are.

Am I affected

You're affected if you are a surgical facility or healthcare provider that received or implanted XTANT MEDICAL Xpress Pedicle Screw System Part Number X073-6555-DL (6.5 x 50 mm) from the affected lot. Check your inventory and surgical records for this specific part number and lot code.

What to do right now

Contact XTANT Medical Holdings, Inc. immediately to identify whether you received units from the affected lot and to verify the correct screw length of any implanted devices. Do not use any units with uncertain labeling until the lot has been verified.

The hazard

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

Brands affected

XTANT Medical Holdings, Inc
Source
FDA
Category
Medical Devices
Recall ID
fda-Z-1773-2026
Classification
Class II
Recalled
February 18, 2026
Read the official notice

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