FDAClass IIIDecember 4, 2019

Intersomatic JULIET Ti OL cage. For use in orthopedic recall

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

Why was Intersomatic JULIET Ti OL cage. For use in orthopedic recalled?

Inner blister pack label is incorrect and does not match the correct external box label.

What should I do if I have this product?

Review the official FDA enforcement record for current 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?

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

Product
Intersomatic JULIET Ti OL cage. For use in orthopedic spinal procedures
Recalling firm
SPINEART SA
Quantity
14 pieces distribtued to 1 US Distributor
Distribution
US: CA OUS: Unknowns
Recall date
December 4, 2019
Classification
Class III
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls