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.
Inner blister pack label is incorrect and does not match the correct external box label.
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.
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.
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.
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.
Verify that the inner blister pack label matches the external box label (model JUT-OX 28 09-S and lot 4-2899).
The inner blister pack label does not match the correct external box label, which could cause confusion during surgical procedures.
Check that the inner blister pack label matches the external box label (model JUT-OX 28 09-S and lot 4-2899). If not, contact SPINEART for guidance.
The recall record does not mention a remedy or replacement option.
We’ve drafted a message you can send SPINEART to request your refund or repair — edit it as you like.
Subject: Recall Z-0546-2020 — SPINEART SPINEART Hello, I own a SPINEART that is covered by recall Z-0546-2020 from SPINEART. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.