Events

Recall of Device Recall Genesys spine, Binary Screwdriver

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Genesys Orthopedics Systems, LLC.

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
    78181
  • Event Risk Class
    Class 2
  • Event Number
    Z-0040-2018
  • Event Initiated Date
    2015-11-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-07-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=158848
  • 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
    Screwdriver, surgical - Product Code LRZ
  • Reason
    Unanticipated technique for a cervical screw insertion caused the tip of the threaded inner shaft to break off.
  • Action
    Genesys Spine initiated their field action on November 15, 2015, by letter. The letter explained how and why the instrument failed and provided updated instructions on how the instrument was to be used. Consignees were provided the option to exchange the unit for another model. The firm expanded the action on September 22, 2017, to request the return of the product. On September 27, 2017, the firm sent a notice to three distributors who were not identified in the original group of consignees. For further questions, please call (512) 381-7070.

Device

Device Recall Genesys spine, Binary Screwdriver
  • Model / Serial
    Lot numbers: 10923, 109231, 11476, 11993, WT20150630A
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US Distribution to the states of : FL, TX, NY, IL, GA, AL, MA, MO
  • Product Description
    Genesys spine, Binary Screwdriver, GCP221, component of the Binary Anterior Cervical Plating System || The Genesys Spine Binary Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to C7). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), spondylolisthesis, trauma (i.e. fractures or dislocations), tumors, deformity (defined as kyphosis, lordosis, or scoliosis),pseudoarthrosis, failed previous fusion, and/or spinal stenosis.
  • Manufacturer
    Genesys Orthopedics Systems, LLC

Manufacturer

Genesys Orthopedics Systems, LLC
  • Manufacturer Address
    Genesys Orthopedics Systems, LLC, 1250 S Capital of Texas Hwy Ste 600, Bldg # 3, West Lake Hills TX 78746-6446
  • Manufacturer Parent Company (2017)
    Genesys Orthopedics Systems LLC
  • Source
    USFDA