Events

Recall of Device Recall StaXx IB Convex Expandable Implant

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

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
    65968
  • Event Risk Class
    Class 2
  • Event Number
    Z-2187-2013
  • Event Initiated Date
    2013-05-14
  • Event Date Posted
    2013-09-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-02-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=121101
  • 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
    Intervertebral fusion device with bone graft, lumbar - Product Code MAX
  • Reason
    A component superior endplate manufactured from a different polymer than specified.
  • Action
    Spine Wave notified surgeons verbally on 5/14/13 and followed by written notification on June 6, 2013 of the incorrect polymer used for the endplate and the health risks.

Device

Device Recall StaXx IB Convex Expandable Implant
  • Model / Serial
    Lot Numbers: 272L08 and 272L09
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Distributed in the states of FL and OR.
  • Product Description
    StaXx¿ IB Convex Expandable Implant (25 x 12 x 9 mm), Intervertebral Fusion Device, Lumbar; Catalog Number 11 -1902. || Indicated for intervertebral body fusion procedures in skeletally mature patients.
  • Manufacturer
    Spine Wave, Inc.

Manufacturer

Spine Wave, Inc.
  • Manufacturer Address
    Spine Wave, Inc., 3 Enterprise Dr Ste 302, Shelton CT 06484-4694
  • Manufacturer Parent Company (2017)
    Spine Wave Inc
  • Source
    USFDA