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.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
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:
Related recalls
Same manufacturer · SPINEART SA
See all →- HighPolyaxial screws in lot 8-4528 recalled over possible incorrect labeling
FDA (Devices) · 2025-08-20
- HighCannulated fenestrated polyaxial screws recalled because they may be incorrectly labeled
FDA (Devices) · 2025-08-20
- HighSpinal Fusion Device Recall: Setscrew Insertion and Tightening Issues
FDA (Devices) · 2024-05-15
- HighLateral lumbar spine implant plate may disassemble during surgery
FDA (Devices) · 2023-05-03
- HighPERLA TL Lateral Connector Open Spinal Fusion Devices Recalled for External Label Error
FDA (Devices) · 2021-07-07
Same hazard · mis labeling
See all →- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-10-14
- LowMindray ePM Series Patient Monitor Manuals Recalled for Alarm Clarification
FDA (Devices) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- HighJ K Patisserie Chocolate Chip Cookies Recalled for Undeclared Soy
FDA (Food) · 2026-10-14
Similar recalls
- ModerateIntervertebral fusion implants recalled over incorrect width printed on side labels
FDA (Devices) · 2025-09-17
- ModerateZimmer Biomet Recalls Vanguard Knee System Due to Label Mismatch
FDA (Devices) · 2018-11-28
- ModerateZimmer Biomet Recalls OSS Cemented IM Stem Due to Labeling Error
FDA (Devices) · 2018-01-10
- ModerateBiomet Spine Recalls Solitaire Ti Spacers Due to Mislabeled Lordotic Angle
FDA (Devices) · 2016-04-06
- HighOPTETRAK LOGIC Tibial Inserts recalled for inadequate packaging oxygen barrier
FDA (Devices) · 2021-10-13
- ModeratePega Medical Recalls Fassier-Duval IM Telescopic System Due to Labeling Error
FDA (Devices) · 2014-04-30