XTANT Medical Holdings, Inc recalls XTANT MEDICAL Xpress Pedicle Screw System Dual Lead 6.5 x 50
See all recalls from XTANT Medical Holdings, Inc →Recalled Product
XTANT MEDICAL Xpress Pedicle Screw System Dual Lead 6.5 x 50 mm, Part Number X073-6555-DL.
Hazard / Issue
Units from one lot were mislabeled with an incorrect part number, identifying the device as a shorter screw length than it physically is.
Issued by
FDA
Affected States: OR
Lot/Code Info: UDI/DI M697X0736555DL1, Lot Number 4375-01
✅ What Should You Do?
- 1Contact your healthcare provider immediately to discuss this recall.
- 2Stop using the device if it is safe to do so, and contact your provider.
- 3Follow the manufacturer's remedy instructions provided in the recall notice.
- 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.
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