SPINEART recalls TRYPTIK 2C-Plate self-tapping screws with incorrect labeling that may show a self-drilling screw sketch instead of intended design. Affected units include specific batch numbers for spinal surgery implants.
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 that have incorrect labeling showing a self-drilling screw sketch instead of the intended design. This could lead to improper use during spinal surgery if the screws are not correctly identified.
The product labeling contains a sketch of a self-drilling screw instead of the intended design. This could cause confusion during spinal surgery if the screws are not correctly identified, potentially leading to improper use.
Spinal surgery patients and medical professionals using the TRYPTIK 2C-Plate system. Those with the specific batch numbers 3-8869 or 3-5933 are most at risk.
Check for the product name 'TRYPTIK 2C-Plate Anterior Cervical Plate System' with batch numbers 3-8869 or 3-5933. The screws are used in spinal surgery for temporary stabilization.
Verify the product label shows the correct design for the screw, not a self-drilling screw sketch.
The affected batch numbers are 3-8869 and 3-5933.
The product labeling contains a sketch of a self-drilling screw instead of the intended design, which could cause confusion during spinal surgery.
The official recall does not provide a fix; users should check the labeling to ensure correct identification.
We’ve drafted a message you can send SPINEART to request your refund or repair — edit it as you like.
Subject: Recall Z-0336-2018 — SPINEART SPINEART Hello, I own a SPINEART that is covered by recall Z-0336-2018 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.
