Warning
XTANT Medical Holdings Recalls XTANT MEDICAL Xpress Pedicle Screw System Dual Lead 6.5 x
This is a Class II recall. This product may cause temporary health problems or pose a slight threat of a serious nature.
Source: FDA
WarningRecall #Z-1773-2026Medical Device
XTANT Medical Holdings Recalls XTANT MEDICAL Xpress Pedicle Screw System Dual Lead 6.5 x
XTANT Medical Holdings, Inc · Class II — Moderate Risk
Product Description
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.
FDA Classification
Class II — Moderate Risk
A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Distribution
US: OR
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
411 Press Analysis
The FDA classified this recall as Class II, indicating the medical device may cause temporary health problems or poses a slight threat of a serious nature. XTANT Medical Holdings, Inc initiated the recall on February 18, 2026 affecting 2 units. Units from one lot were mislabeled with an incorrect part number, identifying the device as a shorter screw length than it physically is. The product was distributed in US: OR. Consumers should check their purchases and discontinue use of any affected product. Contact XTANT Medical Holdings, Inc for further instructions.
Sources: FDA openFDA Enforcement Database
This recall appears in: Medical Device Defects.