Events

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

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by SPINEART SA.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    78640
  • Event Risk Class
    Class 2
  • Event Number
    Z-0341-2018
  • Event Initiated Date
    2017-11-27
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=160055
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Appliance, fixation, spinal intervertebral body - Product Code KWQ
  • 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.
  • 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..

Device

Device Recall TRYPTIK(R) 2 CPLATE SELFTAPPING POLYAXIAL SCREW
  • Model / Serial
    batch: 3-5938
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US Distribution to the state of : CA
  • 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.
  • Manufacturer
    SPINEART SA

Manufacturer

SPINEART SA
  • Manufacturer Address
    SPINEART SA, route de Pre bois 20, Case Postale 1813, Geneva 15 Switzerland
  • Manufacturer Parent Company (2017)
    Spineart Sa
  • Source
    USFDA