Warning
XTANT Medical Holdings Recalls XTANT MEDICAL Xpress Pedicle Screw System Dual Lead 6
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
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.
Sources: FDA openFDA Enforcement Database