FDA DeviceClass IINotable

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

Date: 2026-04-15
Brand: XTANT Medical Holdings, Inc
Category: Medical Device
FDA Class: Class II

Description

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

Hazard

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

Remedy

2 units

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