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Recall Observatory FDA recall evidence

Device product

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.

Z-0338-2018

November 27, 2017

Class II

Product summary

Firm
SPINEART SA
Event
Event 78640
Status
Terminated
Classification
Class II
Quantity
60 units
Official record key
device-enforcement:Z-0338-2018

Official wording

Reason: 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.

Code information: batch: 3-5935

Distribution pattern: US Distribution to the state of : CA

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.