Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.5 MM Recalled by SPINEART SA Due to Product labeling for TRYPTIK 2-C-PLATE Self Tapping screw,...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact SPINEART SA directly.
Affected Products
TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.5 MM, LENGTH 12 MM, REF TRY-PS-45 12-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.
Quantity: 9 units
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed to 1 state: CA
About SPINEART SA
SPINEART SA has 13 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report