SPINEART recalls TRYPTIK 2 C-Plate self-tapping screws with incorrect labeling that may confuse with self-drilling screws. Affected units have a specific reference code and batch number.
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 could lead to confusion with self-drilling screws. This risk may cause improper use during spinal surgery.
The product label incorrectly shows a self-drilling screw sketch instead of the intended self-tapping screw. This could lead to using the wrong screw type during spinal fusion procedures, potentially causing improper stabilization.
Patients undergoing spinal surgery who use these screws for temporary cervical spine stabilization. Surgeons and medical staff handling the product are most at risk.
Check for the reference code TRY-PS-45 18-S and batch number 3-5939 on the packaging. The product is sold as part of the TRYPTIK 2C-Plate Anterior Cervical Plate System.
Look for the reference code TRY-PS-45 18-S and batch number 3-5939 on the packaging.
The product label contains a sketch of a self-drilling screw instead of the intended self-tapping screw, which could lead to improper use during spinal fusion procedures.
Check the product label for the reference code TRY-PS-45 18-S and batch number 3-5939. If it matches, contact SPINEART for further instructions.
The recall is for labeling issues that could lead to improper use, but the remedy does not specify a risk of serious injury. The danger level is low risk.
We’ve drafted a message you can send SPINEART to request your refund or repair — edit it as you like.
Subject: Recall Z-0342-2018 — SPINEART SPINEART Hello, I own a SPINEART that is covered by recall Z-0342-2018 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.
