FDA DeviceClass IINotable
FDA Recall: XTANT MEDICAL Xpress Pedicle Screw System Dual Lead 6.5 x 50 mm, Part Number X073-6555-DL.
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
Related Recalls
2026-06-17 · FDA_DEVICE
FDA Recall: Allia Moveo angiographic X-ray system
GE Medical Systems, LLC
2026-06-17 · FDA_DEVICE
FDA Recall: Brand Name: CGuard¿ Prime Carotid Stent System, 135cm, 8mmx40mm Model/Catalog Number: CND0840
INSPIREMD Inc
2026-06-17 · FDA_DEVICE
FDA Recall: Plum Solo Precision IV Pump, 40001-0401
ICU Medical, Inc.
2026-06-17 · FDA_DEVICE
FDA Recall: Allia IGS 3 Pulse angiographic X-ray system
GE Medical Systems, LLC