Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0342-2018 — TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.5 MM, LENGTH 18 MM, REF TRY-PS-45 18-S, Qty 2 TRYPTIK(R) 2C-Plate Anterior Cervical Plate System is intended to be used for temporary stabilization of the cervical spine (C2-C7) during the development of solid spinal fusion in patients with ins

U.S. FDA — Device Enforcement · Switzerland · 2017-11-27 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0342-2018
Date of alert: 2017-11-27
Country / jurisdiction: Switzerland
Risk level: Class II
Risk type: recall
Brand: SPINEART SA
Product category: device
Product type: Devices

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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