Events

Recall of Zimmer Cannulated Screw System Cannulated Driver, 5.0 mm Hex, REF 1147-49-50; Catalog # 00-1147-049-50. Manufactured by Pioneer Surgical Technology, Marquette, MI; Distributed by Zimmer, Warsaw, IN.

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
    34922
  • Event Risk Class
    Class 2
  • Event Number
    Z-0872-06
  • Event Initiated Date
    2006-03-03
  • Event Date Posted
    2006-05-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-12-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=44953
  • 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
    Screw, Fixation, Bone - Product Code HWC
  • Reason
    There may be an obstruction in the cannula that will prevent the guide wire from passing through it. the obstruction in the cannula can force the guidewire to advance further into the patient than intended.
  • Action
    Pioneer notified Zimmer via letter dated 3/3/06 and Zimmer notified their hospital customers and distribution sites via letters dated 3/10/06 to check their inventory and return the product immediately to Zimmer.

Device

Zimmer Cannulated Screw System Cannulated Driver, 5.0 mm Hex, REF 1147-49-50; Catalog # 00-1147-0...
  • Model / Serial
    Lots 51198300, 51217200, 51234800, 51260000 and 51302600.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide.
  • Product Description
    Zimmer Cannulated Screw System Cannulated Driver, 5.0 mm Hex, REF 1147-49-50; Catalog # 00-1147-049-50. Manufactured by Pioneer Surgical Technology, Marquette, MI; Distributed by Zimmer, Warsaw, IN.
  • Manufacturer
    Pioneer Surgical Technology

Manufacturer

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