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Lower risk Medical device recall · FDA · Published February 5, 2019

SPINEART JULIET Ti OL Cage Recall: Incorrect Label on Inner Blister Pack

SPINEART recalls JULIET Ti OL cage for orthopedic spinal procedures due to incorrect inner blister pack labeling. This mismatch may cause confusion in surgical use.

🇺🇸 FDA recall #Z-0546-2020Medical deviceSPINEART ›
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Recalling firmSPINEART SAChemin Du Pre-Fleuri 3 · Plan-Les-Ouates, Switzerland
✎ GovInfoNow plain-language explainer

What happened, in plain English

SPINEART is recalling its JULIET Ti OL cage used in spinal surgery because the inner blister pack label doesn't match the external box label. This mismatch could lead to confusion during surgical procedures. Read more at govinfonow.com/recall/69051-spineart-juliet-ti-ol-cage-recall-incorrect-label-on-inner.

Source Summary by GovInfoNow · govinfonow.com/recall/69051-spineart-juliet-ti-ol-cage-recall-incorrect-label-on-inner · Updated August 20, 2026 · FDA enforcement record: FDA #Z-0546-2020

Cite this page

“SPINEART JULIET Ti OL Cage Recall: Incorrect Label on Inner Blister Pack.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69051-spineart-juliet-ti-ol-cage-recall-incorrect-label-on-inner. Based on FDA recall #Z-0546-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0546-2020%22&limit=1).

Why it’s dangerous

The inner blister pack label does not match the external box label. This mismatch could cause confusion during surgical procedures, potentially leading to incorrect use of the device.

Who’s affected

Orthopedic surgeons and medical professionals who use the JULIET Ti OL cage for spinal procedures. Those handling the specific model with the described labeling issue are most at risk.

How to tell if you have this one

Check for the model number JUT-OX 28 09-S and lot number 4-2899 on the external box. The inner blister pack label should match this information.

  • Brand
    SPINEART
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Labels

    Verify that the inner blister pack label matches the external box label (model JUT-OX 28 09-S and lot 4-2899).

Where it went and when

Where it was distributed

Distributed in California.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: not listedNHWashington: not listedWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: not listedMNIllinois: not listedILWisconsin: not listedWIMichigan: not listedMINew York: not listedNYRhode Island: not listedRIMassachusetts: not listedMAOregon: not listedORNevada: not listedNVWyoming: not listedWYSouth Dakota: not listedSDIowa: not listedIAIndiana: not listedINOhio: not listedOHPennsylvania: not listedPANew Jersey: not listedNJConnecticut: not listedCTCalifornia: yesCAUtah: not listedUTColorado: not listedCONebraska: not listedNEMissouri: not listedMOKentucky: not listedKYWest Virginia: not listedWVVirginia: not listedVAMaryland: not listedMDDelaware: not listedDEArizona: not listedAZNew Mexico: not listedNMKansas: not listedKSArkansas: not listedARTennessee: not listedTNNorth Carolina: not listedNCSouth Carolina: not listedSCDistrict of Columbia: not listedDCOklahoma: not listedOKLouisiana: not listedLAMississippi: not listedMSAlabama: not listedALGeorgia: not listedGAHawaii: not listedHITexas: not listedTXFlorida: not listedFL

FDA distribution: “US: CA OUS: Unknowns” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: California.

Recall timeline

FDA terminated this recall 2.2 years after the firm started it.

1. Firm started the recall: Feb 5, 201912. FDA classified it Class III: Nov 22, 201923. Published in FDA’s Enforcement Report: Dec 4, 201934. FDA terminated the recall: Apr 28, 2021420192021
  1. Firm started the recall
  2. FDA classified it Class III
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-0546-2020 (February 5, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0546-2020 to see it in context.
  • Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA