Events

Recall of Device Recall Stayfuse

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
    28213
  • Event Risk Class
    Class 3
  • Event Number
    Z-0561-04
  • Event Initiated Date
    2004-01-20
  • Event Date Posted
    2004-02-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-05-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=31386
  • 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
    Product labeled as size 3.8x6 mm implant may actually be size 4.3x6 mm implant.
  • Action
    Zimmer was notified of this recall via letter dated 1/20/04 requesting Zimmer to remove all of this lot from inventory and from point of use locations.

Device

Device Recall Stayfuse
  • Model / Serial
    Lot 77097300.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    By Zimmer: Nationwide, Australia, Canada, Germany and United Kingdom.
  • Product Description
    Stayfuse brand intramedullary bone screw; MID 3.8 x 6 mm. Zimmer part number 00-2227-003-001.
  • Manufacturer
    Pioneer Surgical Technology

Manufacturer

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