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

Medical DevicesSource: FDA (device) · Date: 2026-04-15

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
XTANT Medical Holdings, Inc
Product
XTANT MEDICAL Xpress Pedicle Screw System Dual Lead 6.5 x 50 mm, Part Number X073-6555-DL.
Reason / hazard
Units from one lot were mislabeled with an incorrect part number, identifying the device as a shorter screw length than it physically is.
Classification
Class II
Status
Ongoing
Distribution / sold at
US: OR
Recall initiated
2026-02-18
Code info
UDI/DI M697X0736555DL1, Lot Number 4375-01
Product quantity
2 units
Voluntary mandated
Voluntary: Firm initiated
City
Belgrade
State
MT
Country
United States
Event id
98541
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