SPINEART recalls TRYPTIK 2 C-Plate self-tapping screws due to incorrect labeling that may confuse with self-drilling screws. Affected products 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 because the product labeling incorrectly shows a self-drilling screw sketch. This could lead to improper use in spinal surgery, but the recall does not specify a safety risk or required action.
The product labeling 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 incorrect implantation.
Patients undergoing spinal surgery who use the TRYPTIK 2 C-Plate system are most at risk. The recall affects specific batch numbers and product references.
Check for the reference code TRY-PS-45 14-S and batch number 3-5937 on the product packaging. The product is used in spinal fusion procedures for cervical spine stabilization.
Look for the reference code TRY-PS-45 14-S and batch number 3-5937 on the product packaging.
The recall record does not specify a safety risk or injury mechanism.
The recall record does not provide a remedy or action steps for affected products.
Products with reference code TRY-PS-45 14-S and batch number 3-5937.
We’ve drafted a message you can send SPINEART to request your refund or repair — edit it as you like.
Subject: Recall Z-0340-2018 — SPINEART SPINEART Hello, I own a SPINEART that is covered by recall Z-0340-2018 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.
