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U.S. Department of Health and Human Services

Class 3 Device Recall Intersomatic JULIET Ti OL cage

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 Class 3 Device Recall Intersomatic JULIET Ti OL cagesee related information
Date Initiated by FirmFebruary 05, 2019
Date PostedNovember 22, 2019
Recall Status1 Terminated 3 on April 28, 2021
Recall NumberZ-0546-2020
Recall Event ID 84219
510(K)NumberK153621 
Product Classification Intervertebral fusion device with bone graft, lumbar - Product Code MAX
ProductIntersomatic JULIET Ti OL cage. For use in orthopedic spinal procedures
Code Information Model Number: JUT-OX 28 09-S Lot Number: 4-2899 UDI: (01) 0 7640178 97398 5 (11) 181102 (17) 261101 (10) 4-2899
Recalling Firm/
Manufacturer		 SPINEART SA
Chemin Du Pre-Fleuri 3
Plan-Les-Ouates Switzerland
Manufacturer Reason
for Recall		Inner blister pack label is incorrect and does not match the correct external box label.
FDA Determined
Cause 2		Employee error
ActionOn 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 in Commerce14 pieces distribtued to 1 US Distributor
DistributionUS: CA OUS: Unknowns
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = MAX
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