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U.S. Department of Health and Human Services

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

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  Class 2 Device Recall TRYPTIK(R) 2 CPLATE SELFTAPPING POLYAXIAL SCREW see related information
Date Initiated by Firm November 27, 2017
Create Date January 13, 2018
Recall Status1 Terminated 3 on August 27, 2019
Recall Number Z-0337-2018
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 14 MM, REF TRY-PS-40 14-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: 3-5934
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 2		 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 120 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 and Original Applicant = SPINEART
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