Events

Recall of Pioneer Quantum Spinal Rod System

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

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
    45526
  • Event Risk Class
    Class 2
  • Event Number
    Z-0291-2008
  • Event Initiated Date
    2007-10-10
  • Event Date Posted
    2007-11-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-03-31
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=65733
  • 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
    Yoke Manipulator - Product Code HWR
  • Reason
    The pins may come out of the instrument and, if this happens, they could fall into/remain in the patient.
  • Action
    Consignees were notified via a Product Recall letter dated 10/10/07 to remove these instruments from their instrument cases and to return them to the firm.

Device

Pioneer Quantum Spinal Rod System
  • Model / Serial
    Lot 013886.
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide: including states of California, Florida, Michigan and North Carolina.
  • Product Description
    Pioneer Quantum Spinal Rod System, MIS Yoke Manipulator, Long Slot, non-sterile; Cat # 51-YOKEMAN-L, Pioneer Surgical Technology, Marquette, MI 49855
  • Manufacturer
    Pioneer Surgical Technology

Manufacturer

Pioneer Surgical Technology
  • Manufacturer Address
    Pioneer Surgical Technology, 375 River Park Cir, Marquette MI 49855-1781
  • Source
    USFDA