Events

Recall of Device Recall Songer Spinal Cable System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by RTI Surgical, Inc. (dba Pioneer Surgical Technology, 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
    71474
  • Event Risk Class
    Class 2
  • Event Number
    Z-2053-2015
  • Event Initiated Date
    2015-05-29
  • Event Date Posted
    2015-07-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-03-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=137919
  • 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
    Cerclage, fixation - Product Code JDQ
  • Reason
    The box end label is incorrectly labeled as titanium instead of stainless steel on one lot of implantable songer spinal cable system, single cable, crimp, bar, stainless steel, sterile, distributed by depuy spine inc.
  • Action
    On 5/29/15, RTI Surgical sent DePuy/Synthes Spine Inc. with an URGENT: Medical Device Voluntary Recall Notification identifying the recalled product, reason for recall, potential risks, and immediate actions required.

Device

Device Recall Songer Spinal Cable System
  • Model / Serial
    Lot Number: PL 193368 Manufacture Date: 09/09/2014 Expiration Date: 09/09/2019
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Distributed in MA.
  • Product Description
    Songer Spinal Cable System, Single Cable, Crimp, Bar, Stainless Steel, Sterile. || The DePuy Spine Cable System can be utilized anywhere monofilament wire has been previously found to be indicated.
  • Manufacturer
    RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)

Manufacturer

RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
  • Manufacturer Address
    RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.), 375 River Park Cir, Marquette MI 49855-1781
  • Manufacturer Parent Company (2017)
    RTI Surgical Inc
  • Source
    USFDA