Home / Recalls / SPINEART SA / Z-0341-2018

Z-0341-2018 Class II Terminated

Recalled by SPINEART SA — Geneva 15, N/A

Recall Details

Product Type
Devices
Report Date
January 24, 2018
Initiation Date
November 27, 2017
Termination Date
August 27, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
15 units

Product Description

TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.5 MM, LENGTH 16 MM, REF TRY-PS-45 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.

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 Pattern

US Distribution to the state of : CA

Code Information

batch: 3-5938

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  • Z-0340-2018 Class II — TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.5 MM, LENGTH 14 MM, REF TRY- (November 27, 2017)
  • Z-0336-2018 Class II — TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.0 MM, LENGTH 12 MM, REF TRY- (November 27, 2017)