XTANT MEDICAL Xpress Pedicle Screw System Dual Lead 6.5 x 50 mm, Part Number X073-6555-DL.
Class I - DangerousWhat Should You Do?
- Check if you have this product: UDI/DI M697X0736555DL1, Lot Number 4375-01
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- XTANT Medical Holdings, Inc
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
XTANT MEDICAL Xpress Pedicle Screw System Dual Lead 6.5 x 50 mm, Part Number X073-6555-DL.
Product Codes/Lot Numbers:
UDI/DI M697X0736555DL1, Lot Number 4375-01
Distribution:
Distributed in: US, OR
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1773-2026
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