SPINEART recalls TRYPTIK 2C-Plate screws with batch 3-5934 due to incorrect labeling showing a self-drilling screw sketch. This may cause confusion in surgical use. Affected patients should contact SPINEART for guidance.
Product labeling for TRYPTIK 2-C-PLATE Self Tapping screw, REF TRY-PS 40, Lot 3-5934 contains the sketch/drawing of a self-drilling screw.
SPINEART is recalling TRYPTIK 2C-Plate self-tapping screws with batch number 3-5934 because the product labeling incorrectly shows a self-drilling screw sketch. This could lead to confusion during surgical procedures, potentially affecting spinal stabilization.
The product labeling for these screws incorrectly includes a sketch of a self-drilling screw instead of the intended self-tapping screw. This could cause confusion during surgical procedures, potentially leading to improper spinal stabilization.
Patients who received the TRYPTIK 2C-Plate system with batch 3-5934 for cervical spine stabilization are affected. Surgeons and medical staff using this specific batch are at highest risk.
Check for the batch number 3-5934 on the TRYPTIK 2C-Plate system packaging. The product is intended for temporary cervical spine stabilization in patients with spinal instability.
Reach out to SPINEART directly for guidance on the recalled product and next steps.
The product labeling for TRYPTIK 2C-Plate screws with batch 3-5934 incorrectly shows a sketch of a self-drilling screw instead of the intended self-tapping screw.
Contact SPINEART directly for guidance on the recalled product and next steps.
The recall is due to labeling confusion, not an immediate safety hazard. The risk is low and related to potential surgical errors.
We’ve drafted a message you can send SPINEART to request your refund or repair — edit it as you like.
Subject: Recall Z-0337-2018 — SPINEART SPINEART Hello, I own a SPINEART that is covered by recall Z-0337-2018 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.
