Events

Recall of Device Recall SST TWIST DRILL, STANDARD, 1.6mm Dia. x 127mm, REF 8054010, STERILE

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
    78687
  • Event Risk Class
    Class 2
  • Event Number
    Z-0412-2018
  • Event Initiated Date
    2017-05-22
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=160119
  • 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
    Bit, drill - Product Code HTW
  • Reason
    One lot was found to contain both the correct twist drill (1.6mm) as well as an incorrect twist drill (2.0mm).
  • Action
    MicroAire Surgical Instruments, LLC distributed recall letters on May 22, 2017 MicroAire Surgical Instruments, LLC distributed recall letters to the customers who received the mislabeled twist. Letters will be sent by UPS to expedite the delivery. For further questions, please call (434) 975-8000

Device

Device Recall SST TWIST DRILL, STANDARD, 1.6mm Dia. x 127mm, REF 8054010, STERILE
  • Model / Serial
    LIT 0317305390
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US Distribution.
  • Product Description
    SST TWIST DRILL, STANDARD, 1.6mm Dia. x 127mm, REF 8054-010, STERILE || This product line is intended for use in orthopaedic surgery (large and small bone surgeries) to cut bone
  • 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