Recall of Device Recall MicroAire KWires

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

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
    76560
  • Event Risk Class
    Class 2
  • Event Number
    Z-1407-2017
  • Event Initiated Date
    2017-02-21
  • Event Date Posted
    2017-03-03
  • Event Status
    Terminated
  • Event Country
  • Event Terminated Date
    2017-07-14
  • Event Source
    USFDA
  • Event Source URL
  • 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
    Pin, fixation, smooth - Product Code HTY
  • Reason
    Mislabeling on three lots of k-wires. the incorrect product description " dual trocar" instead of "single trocar" was on the product label on the following parts: 1600-9355ns (lot 61005), 1600-9625ns (lot 60297), and 1604-162ns (lot 62856).
  • Action
    The firm will mail recall letters to the customers who received the mislabeled k-wires on February 21, 2017. Letters will be sent by UPS to expedite the delivery. The firm will contact the non-responding accounts at least two more times.

Device

  • Model / Serial
    Part Number, Lot Number, Quantity Distributed to Field 1600-9355NS, 61005, 56; 1600-9625NS, 60297, 209; 1604-162NS, 62856, 97.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    United States.
  • Product Description
    MicroAire K-Wires
  • Manufacturer

Manufacturer

  • Manufacturer Address
    MicroAire Surgical Instruments, LLC, 3590 Grand Forks Blvd, Charlottesville VA 22911-9006
  • Manufacturer Parent Company (2017)
  • Source
    USFDA