SPINEART recalls TRYPTIK 2 C-Plate self-tapping screws with incorrect labeling that may show a self-drilling screw sketch. This could lead to improper use in spinal surgery. Affected units include specific model and batch numbers.
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 2 C-Plate self-tapping screws due to incorrect labeling that shows a sketch of a self-drilling screw instead of the intended product. This could cause improper use during spinal surgery if the screws are not correctly identified.
The product labeling incorrectly shows a sketch of a self-drilling screw instead of the intended self-tapping screw. This could lead to confusion during spinal surgery if the wrong screw type is used, potentially causing improper stabilization.
Patients undergoing spinal surgery who use the TRYPTIK 2 C-Plate system are most at risk. The recall affects specific model numbers and batches sold for temporary spinal stabilization.
Check for the model number TRY-PS-45 16-S and batch number 3-5938 on the packaging. The product is intended for temporary spinal stabilization in patients with cervical spine instability.
Verify the model number and batch number on the packaging to confirm if it matches the recalled items.
The product labeling incorrectly shows a sketch of a self-drilling screw instead of the intended self-tapping screw, which could lead to confusion during spinal surgery.
The affected model is TRY-PS-45 16-S with batch number 3-5938.
The recall record does not specify a remedy, so no action is required beyond checking the labeling.
We’ve drafted a message you can send SPINEART to request your refund or repair — edit it as you like.
Subject: Recall Z-0341-2018 — SPINEART SPINEART Hello, I own a SPINEART that is covered by recall Z-0341-2018 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.
