XTANT MEDICAL Xpress Pedicle Screw System Dual Lead 6.5 x 50 mm, Part Number X073-6555-DL. – Units from one lot were mislabeled with an incorrect part… – XTANT Medical Holdings, Inc

← Back to Medical Device Recalls

Recall Category: Medical Device Recalls

Recalling Firm: XTANT Medical Holdings, Inc

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

Reason for Recall: 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

Report Date: 04/15/2026

Recall Initiation Date: 02/18/2026

Distribution: US: OR

Code Info: UDI/DI M697X0736555DL1, Lot Number 4375-01

Product Quantity: 2 units

Recall Type: Voluntary: Firm initiated

Initial Firm Notification: Letter

Firm Location: Belgrade, MT, United States

Recall Number: Z-1773-2026

Event ID: 98541

Search FDA Medical Device Recall Records