Class 2 Device Recall TRYPTIK(R) 2 CPLATE SELFTAPPING POLYAXIAL SCREW

• Date Initiated by Firm: November 27, 2017
• Create Date: January 13, 2018
• Recall Status: Terminated on August 27, 2019
• Recall Number: Z-0338-2018
• Recall Event ID: 78640
• 510(K)Number: K153042
• Product Classification: Appliance, fixation, spinal intervertebral body - Product Code KWQ
• 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.
• Code Information: batch: 3-5935
• Recalling Firm/ Manufacturer: SPINEART SA; route de Pre bois 20; Case Postale 1813; Geneva 15 Switzerland
• For Additional Information Contact: 949-313-6400
• Manufacturer 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.
• FDA Determined Cause: Error in labeling
• Action: Spineart sent an Urgent Medical Device letter by email dated November 27, 2017. The letter stated the following: "Out of an abundance of caution", we have decided to recall the concerned products. Please carefully follow instructions detailed below: 1. Immediately examine your inventory and quarantine product subject to recall. 2. In addition, if you may have further distributed this product, please identify your customers and notify them at once of this product recall by using this document. 3. Collect and quarantine all products. 4. Send back all products and the enclosed Response Form to Spineart Geneva E-mail: regulatory@spineart.com." For further questions, please call (949) 313-6400..
• Quantity in Commerce: 60 units
• Distribution: US Distribution to the state of : CA
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = KWQ