SPINEART recalls TRYPTIK 2C-Plate screws with incorrect labeling that may show a self-drilling screw sketch. Affected products include specific model and batch numbers. Consumers should check their items and contact SPINEART for details.
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 due to incorrect labeling that includes a sketch of a self-drilling screw. This could lead to improper use in spinal surgery. Affected products have specific model and batch numbers.
The product labeling incorrectly shows a sketch of a self-drilling screw instead of the intended self-tapping screw. This could lead to improper surgical application if the screw is used without the correct design features.
Patients undergoing spinal surgery who use TRYPTIK 2C-Plate systems are most at risk. The recall affects specific model and batch numbers of screws used in cervical spine stabilization.
Check for the model number TRY-PS-45 12-S and batch number 3-5936 on the screw packaging. The product is part of the TRYPTIK 2C-Plate Anterior Cervical Plate System used for cervical spine stabilization.
Look for the model number TRY-PS-45 12-S and batch number 3-5936 on the screw packaging.
The recalled screws have model number TRY-PS-45 12-S and batch number 3-5936.
The product labeling contains a sketch of a self-drilling screw instead of the intended self-tapping screw, which could lead to improper surgical application.
The recall record does not specify a remedy, so there is no instruction to stop using the product.
We’ve drafted a message you can send SPINEART to request your refund or repair — edit it as you like.
Subject: Recall Z-0339-2018 — SPINEART SPINEART Hello, I own a SPINEART that is covered by recall Z-0339-2018 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.
