# FDA recall Z-0342-2018

> **SPINEART SA** · Class II · device recall initiated 2017-11-27.

## Product

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 instability caused by the following degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumor, spondylolisthesis, spinal stenosis, deformity (i.e., scoliosis, kyphosis, lordosis), pseudarthrosis, and failed previous fusions.

## Reason for recall

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.

## Distribution

US Distribution to the state of : CA

## Key facts

- **Recall number:** Z-0342-2018
- **Recalling firm:** SPINEART SA
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-11-27
- **Report date:** 2018-01-24
- **Termination date:** 2019-08-27

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Geneva 15, N/A, Switzerland

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0342-2018

## Citation

> AI Analytics. FDA recall Z-0342-2018. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/Z-0342-2018. Source: US FDA. Licensed CC0.

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