Reported Dec 4, 2019 · Terminated
Intersomatic JULIET Ti OL cage. For use in orthopedic spinal procedures
Spineart Sa
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: SPINEART SA · Chemin Du Pre-Fleuri 3 · Plan-Les-Ouates · N/A
Is this the product you have?
- Intersomatic JULIET Ti OL cage. For use in orthopedic spinal procedures
- Lot codes and dates
- Model NumberJUT-OX 28 09-S
- Lot Number4-2899
- UDI(01) 0 7640178 97398 5 (11) 181102 (17) 261101 (10) 4-2899
- Amount recalled
- 14 pieces distribtued to 1 US Distributor
Where it was sold
Why it was recalled
Inner blister pack label is incorrect and does not match the correct external box label.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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