Spineart JULIET Ti OL Cage Recalled for Incorrect Inner Blister Label
Spineart SA is recalling 14 JULIET Ti OL cages due to a mismatch between the inner blister pack label and the external box label.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences. The issue is a labeling discrepancy rather than a functional defect or contamination.
Plain-English summary
Spineart SA is recalling 14 pieces of the Intersomatic JULIET Ti OL cage, a medical device used for orthopedic spinal procedures. The recall was initiated because the label on the inner blister pack is incorrect and does not match the label on the correct external box.
The affected units are identified by Model Number JUT-OX 28 09-S and Lot Number 4-2899. The source text indicates that these 14 pieces were distributed to one US distributor in California, while the distribution status outside the US is unknown.
Healthcare providers and patients who have received or used these specific devices should contact Spineart SA for further instructions. The recall is classified as Class III by the FDA, indicating that the use of or exposure to the device is not likely to cause adverse health consequences.
The recalled product
- Product
- Intersomatic JULIET Ti OL cage. For use in orthopedic spinal procedures
- Manufacturer
- SPINEART SA
- Hazard
Distribution
Distributed in 1 state:
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