CLASS III Device recall · Reported 4 Dec 2019 · FDA Enforcement Report
Intersomatic Juliet Ti OL cage recalled by Spineart
Spineart is recalling Intersomatic Juliet Ti OL cage, distributed in California. The recall was initiated on 5 Feb 2019 and the FDA has classified it as Class III.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0546-2020
- FDA event ID
- 84219
- Recalling firm
- Spineart, Plan-Les-Ouates
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 5 Feb 2019
- FDA classified
- 22 Nov 2019
- Reported
- 4 Dec 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Device Malfunction
- Device type
- Hip & Knee Implants
Timeline
| 5 Feb 2019 | Recall initiated by company | |
| 22 Nov 2019 | Classified by FDA | +290 days |
| 4 Dec 2019 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Inner blister pack label is incorrect and does not match the correct external box label.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Intersomatic JULIET Ti OL cage. For use in orthopedic spinal procedures
Where it was distributed
US: CA OUS: Unknowns
Questions about this recall
Why was it recalled?
Inner blister pack label is incorrect and does not match the correct external box label.
Which lots 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
Where was it sold?
US: CA OUS: Unknowns
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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