SPINEART recalls TRYPTIK 2C-Plate screws with incorrect labeling that may show a self-drilling screw sketch instead of intended design. 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 2C-Plate self-tapping screws due to incorrect labeling that shows a sketch of a self-drilling screw instead of the intended design. This could lead to improper use in spinal surgery.
The product labeling includes a sketch of a self-drilling screw instead of the intended design. This could cause improper installation or function during spinal fusion procedures.
Patients undergoing spinal surgery who received these screws are affected. Surgeons and medical staff using the product for cervical spine stabilization are most at risk.
Check for the model number TRY-PS-40 16-S and batch number 3-5935 on the packaging. The product is intended for temporary cervical spine stabilization in surgical procedures.
Look for the model number TRY-PS-40 16-S and batch number 3-5935 on the packaging.
The recalled model is TRY-PS-40 16-S with batch number 3-5935.
The product labeling contains a sketch of a self-drilling screw instead of the intended design, which could lead to improper use in spinal surgery.
The recall record does not specify a remedy.
We’ve drafted a message you can send SPINEART to request your refund or repair — edit it as you like.
Subject: Recall Z-0338-2018 — SPINEART SPINEART Hello, I own a SPINEART that is covered by recall Z-0338-2018 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.
