Intersomatic JULIET Ti OL cage. For use in orthopedic spinal procedures

Class I - Dangerous

🏥 Medical Devices Recalled: February 5, 2019 SPINEART SA Other Medical Devices

What Should You Do?

Check if you have this product:
Model Number: JUT-OX 28 09-S Lot Number: 4-2899 UDI: (01) 0 7640178 97398 5 (11) 181102 (17) 261101 (10) 4-2899
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:: SPINEART SA
Reason for Recall:: Inner blister pack label is incorrect and does not match the correct external box label.
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: terminated

Product Information

Full Description:

Intersomatic JULIET Ti OL cage. For use in orthopedic spinal procedures

Product Codes/Lot Numbers:

Model Number: JUT-OX 28 09-S Lot Number: 4-2899 UDI: (01) 0 7640178 97398 5 (11) 181102 (17) 261101 (10) 4-2899

Distribution:

Distributed in: US, CA

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0546-2020

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