XTANT MEDICAL Xpress Pedicle Screw System Dual Lead 6.5 recall: Labeling Error
XTANT MEDICAL Xpress Pedicle Screw System Dual Lead 6.5 x 50 mm, Part Number X073-6555-DL.
Why was XTANT MEDICAL Xpress Pedicle Screw System Dual Lead 6.5 recalled?
Units from one lot were mislabeled with an incorrect part number, identifying the device as a shorter screw length than it physically is.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI/DI M697X0736555DL1, Lot Number 4375-01
- Product
- XTANT MEDICAL Xpress Pedicle Screw System Dual Lead 6.5 x 50 mm, Part Number X073-6555-DL.
- Recalling firm
- XTANT Medical Holdings, Inc
- Quantity
- 2 units
- Distribution
- US: OR
- Recall date
- April 15, 2026
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)