SPINEART SA: Medical Device Recall in 2018 - (Recall #: Z-0338-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.0 MM, LENGTH 16 MM, REF TRY-PS-40 16-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.

Product Classification:

Class II

Date Initiated: November 27, 2017

Date Posted: January 24, 2018

Recall Number: Z-0338-2018

Event ID: 78640

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.

Status: Terminated

Product Quantity: 60 units

Code Information:

batch: 3-5935

Distribution Pattern:

US Distribution to the state of : CA

Voluntary or Mandated:

Voluntary: Firm initiated