SPINEART SA recalls Intersomatic JULIET Ti OL cage. For use in orthopedic spinal procedures
- Recall date
- February 5, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0546-2020
- FDA classification
- Class III
- Brand / firm
- SPINEART SA
- Sold / distributed
- US: CA OUS: Unknowns
Why it was recalled
Inner blister pack label is incorrect and does not match the correct external box label.
Class III means the product violates regulations but is not likely to cause harm.
What was recalled
Intersomatic JULIET Ti OL cage. For use in orthopedic spinal procedures
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