Events

Recall of Device Recall 40cm x 4mm Del Vecchio French Rasp cannula

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
    73259
  • Event Risk Class
    Class 2
  • Event Number
    Z-1323-2016
  • Event Initiated Date
    2016-02-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-08-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143637
  • 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
    Pump, portable, aspiration (manual or powered) - Product Code BTA
  • Reason
    Complaints that the cannula bent/broke during surgery.
  • Action
    The firm is sending letters to all customers who have received PAL-R4011XL from August 2013- October 2015. The firm sent these letters by UPS to expedite the delivery and for traceability.

Device

Device Recall 40cm x 4mm Del Vecchio French Rasp cannula
  • Model / Serial
    0913228216, 0414243005, 0215266350, 0415269875, and 0515271334.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution. US nationwide including Puerto Rico, Australia, Bangladesh, Czech Republic, India, Japan, Lebanon, New Zealand, Norway, Singapore, Switzerland, Taiwan, and Turkey.
  • Product Description
    MicroAire PAL-R4011XL - 40cm x 4 mm Del Vecchio French Rasp aspiration cannula
  • Manufacturer
    MicroAire Surgical Instruments, LLC

Manufacturer

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