Z-0546-2020Class III

Intersomatic JULIET Ti OL cage. For use in orthopedic spinal procedures

Name: Z-0546-2020 Intersomatic JULIET Ti OL cage. For use in orthopedic spinal procedures
Creator: Spineart Sa
Published: 2019-02-05
License: https://open.fda.gov/license/

Spineart SA / initiated 2019-02-05 / Terminated / root cause: manufacturing process

FDA source

SPINEART SA began a recall of Intersomatic JULIET Ti OL cage. For use in orthopedic spinal procedures on 2019-02-05. FDA classified it as Class III and gives the reason as "Inner blister pack label is incorrect and does not match the correct external box label". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0546-2020
Classification: Class III
Status: Terminated
Initiated: 2019-02-05
Posted: 2019-11-22
Terminated: 2021-04-28
Recalling firm: Spineart SA
Product: Intersomatic JULIET Ti OL cage. For use in orthopedic spinal procedures
Product code: MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Reason for recall: Inner blister pack label is incorrect and does not match the correct external box label.
Root cause tag: manufacturing process
FDA 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: [email protected]. 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 in commerce: 14 pieces distribtued to 1 US Distributor
Distribution: US: CA OUS: Unknowns
Product codes and lots: Model Number: JUT-OX 28 09-S Lot Number: 4-2899 UDI: (01) 0 7640178 97398 5 (11) 181102 (17) 261101 (10) 4-2899

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0546-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0546-2020	Class III	Terminated	Voluntary: Firm initiated	2019-12-04	2019-11-22

Product code MAX

K153621Class IIJuliet® TiSpineart / cleared 2016-07-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)