Events

Recall of Device Recall Quantum

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
    32949
  • Event Risk Class
    Class 2
  • Event Number
    Z-0021-06
  • Event Initiated Date
    2005-07-29
  • Event Date Posted
    2005-10-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-10-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=41127
  • 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
    Thoracolumbosacral Pedicle Screw System - Product Code NKB
  • Reason
    Screw may be incorrectly etched as to length.
  • Action
    Consignees were notified by letter dated 7/29/05 to inspect stocks in storage and at point of use locations hand for correct length and that a firm representative would visit them to pick up any mis-etched product.

Device

Device Recall Quantum
  • Model / Serial
    Lot 308623.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide.
  • Product Description
    Pioneer Surgical brand Quantum Spinal Rod System Polyaxial Screw, length 40 mm; Catalog number 10-575-PA-40.
  • Manufacturer
    Pioneer Surgical Technology

Manufacturer

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