FDA Medical Device Recalls (openFDA)
SPINEART SA: Intersomatic JULIET Ti OL cage. For use in orthopedic spinal procedures
- Recall number
- Z-0546-2020
- Recalling firm
- SPINEART SA
- Product
- Intersomatic JULIET Ti OL cage. For use in orthopedic spinal procedures
- Status
- Terminated
- Initiated
- 2019-02-05
- Posted
- 2019-11-22
- Terminated
- 2021-04-28
- Reason
- Inner blister pack label is incorrect and does not match the correct external box label.
- Root cause
- Employee error
- Action
- On 02/05/2019, the firm sent an "URGENT: MEDICAL DEVICE RECALL FSCA-04-2019" notification letter via email informing its one U.S. Distributor of the issue of incorrect inner blister pack labeling for Lot Number 4-2899. The customer was instructed to please carefully follow instructions detailed below: 1. Immediately review their inventory and quarantine concerned products if any. 2. For customer who may have further distributed this product to please identify concerned customers and notify them at once of this product recall by using the URGENT: MEDICAL DEVICE RECALL" document. 3. Collect and quarantine all products. 4. Sent back all products with the enclosed Response Form to the Recalling Firm(Chemin du Pr Fleuri 3, 1228 Plan-les-Ouates, Switzerland). E-mail: regulatory@spineart.com. 5. All returned products will be exchanged with batches already available in the Recalling Firm's warehouse. The customers were also informed of the following risks associated with the affected product: The product is always selected before implantation by reading the external label. Consequently, the selection of a wrong size implant can be excluded. At worst the surgeon could be surprised to see that the internal label does not match with the external box label or the product itself regarding the size. A confusion would then be generated. In addition, the patient file information could be partially erroneous as the internal label is usually kept in the records. But the batch number that is good (4-2899) ensures a full traceability.
- Quantity
- 14 pieces distribtued to 1 US Distributor
- Distribution
- US: CA OUS: Unknowns
- Lot, serial or model codes
- Model Number: JUT-OX 28 09-S Lot Number: 4-2899 UDI: (01) 0 7640178 97398 5 (11) 181102 (17) 261101 (10) 4-2899
- 510(k) numbers
- ["K153621"]
- PMA numbers
- not on file
- Product code
- MAX
- Firm FEI
- 3007728266
- Firm city
- Plan-Les-Ouates
- Firm state
- not on file
- Firm country
- Switzerland
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28