Events

Recall of Device Recall Serrated Soft Tissue Shields

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by X Spine Systems 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
    68863
  • Event Risk Class
    Class 2
  • Event Number
    Z-2136-2014
  • Event Initiated Date
    2014-07-11
  • Event Date Posted
    2014-08-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-08-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128882
  • 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
    Guide, surgical, instrument - Product Code FZX
  • Reason
    Revision b of the tissue shields of the device was 7 mm longer than the previous design.
  • Action
    X-Spine systems contacted both customers via telephone and instructed to return the affected product back to X-Spine. All product has been recovered. The distributors have already returned the recalled product. No product was utilized in any surgical procedure. Immediate Action Taken: X-spine inventory was reviewed and two pieces of each size were recovered from finished inventory. The X-spine sales person returned the product. The distributor has returned the remaining product. The devices were recovered prior to use in any surgical procedure. For further questions please call (937) 847-8410

Device

Device Recall Serrated Soft Tissue Shields
  • Model / Serial
    Part numbers X079-0096 and X079-0097 with Lot #12320
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US Distribution including the states of FL and MO.
  • Product Description
    Serrated Soft Tissue Shields. Orthopedic surgical instruments, part of the Silex Sacroiliac Fusion System. The soft tissue shields are surgical instrument guides in the Silex Sacroiliac Joint Fusion System for spinal surgery.
  • Manufacturer
    X Spine Systems Inc

Manufacturer

X Spine Systems Inc
  • Manufacturer Address
    X Spine Systems Inc, 452 Alexandersville Rd, Miamisburg OH 45342-3658
  • Manufacturer Parent Company (2017)
    X-Spine Systems, Inc
  • Source
    USFDA