Events

Recall of Device Recall Endotine Transbleph 3.5

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
    74222
  • Event Risk Class
    Class 2
  • Event Number
    Z-2294-2016
  • Event Initiated Date
    2016-05-06
  • 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=146853
  • 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
    Microaire has initiated a limited recall (29 units)on the endotine transbleph 3.5 (cfd-080-0167), lot # 285373, due to minor mislabeling ( the front label is correct, but the side label lists an incorrect part number, i.E. cfd-080-0177).
  • Action
    The firm is sending recall letters to the customers who have received the Endotine Transbleph 3.5 (CFD-080-0167), lot #285373. Letters sent by UPS to expedite the delivery.

Device

Device Recall Endotine Transbleph 3.5
  • Model / Serial
    Endotine Transbleph 3.5 (CFD-080-0167), Lot # 285373
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    The product was distributed in the United States and Sweden
  • Product Description
    Endotine Transbleph 3.5 (CFD-080-0167)
  • 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