Events

Recall of Device Recall Tritium Sternal Plate System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by 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
    68619
  • Event Risk Class
    Class 2
  • Event Number
    Z-2076-2014
  • Event Initiated Date
    2014-06-11
  • Event Date Posted
    2014-07-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-10-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128318
  • 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
    Lack of sterility assurance.
  • Action
    On 6/11/14 and 6/12/14 the firm contacted their two consignees and surgeon via phone and explained that the product did not go through the sterilization process. The returns authorization number and shipping labels were discussed for the unused unit. On 6/18/14 and 6/20/14 an URGENT: MEDICAL DEVICE VOLUNTARY RECALL NOTIFICATION was sent to the customers as well as the one surgeon. The letter explained the sterility concerns and that the productis being recalled. Contact Dan Nelson, Manager of Quality, at 906-226-4489 if you have any questions or concerns.

Device

Device Recall Tritium Sternal Plate System
  • Model / Serial
    Model: 86-27-12-S12 UDI Number: 00846468061463 LOT: 168952 Expiration:12/23/2018
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US Nationwide Distribution in the states of TX and FL
  • Product Description
    Tritium Sternal Plate System, Screw, 02.7mm X 12mm, 12 Pack, Sterile. || The Pioneer Surgical Cable Plate System is used in the stabilization and fixation of fractures of the anterior chest wall including Sternal fixation following Sternotomy and Sternal reconstructive surgical procedures. The screws are packaged as a 12 pack using a double tray packaging configuration.
  • Manufacturer
    PIONEER SURGICAL TECHNOLOGY, INC.

Manufacturer

PIONEER SURGICAL TECHNOLOGY, INC.
  • Manufacturer Address
    PIONEER SURGICAL TECHNOLOGY, INC., 375 River Park Cir, Marquette MI 49855-1781
  • Manufacturer Parent Company (2017)
    RTI Surgical Inc
  • Source
    USFDA