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

View original recall →
Share:

Related Recalls

2026-08-05 · FDA_DEVICE
FDA Recall: EOPA Elongated One-Piece Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary bypass
Medtronic Perfusion Systems
2026-08-05 · FDA_DEVICE
FDA Recall: AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) ENT Pack, Pack Number AMS12
Windstone Medical Packaging, Inc.
2026-08-05 · FDA_DEVICE
FDA Recall: AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Block Tray - RX, Part Number AMS
Windstone Medical Packaging, Inc.
2026-08-05 · FDA_DEVICE
FDA Recall: AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Nerve Block Tray - RX, Part
Windstone Medical Packaging, Inc.