Events

Recall of MODULAR REVERSE REAMER PILOT TIP

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by EXACTECH INC..

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
    133267
  • Event Risk Class
    II
  • Event Initiated Date
    2017-06-05
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    This advisory notice has been issued because exactech has updated the surgical technique for implantation of the equinoxe platform shoulder system to clarify the proper technique for use of the pilot tip reamers i.E. to include a caution statement that surgeon should avoid applying a bending force to the pilot tip reamer and should avoid using the reamer to retract the humeral head as this may result in instrument breakage.

Device

MODULAR REVERSE REAMER PILOT TIP
  • Model / Serial
    Model Catalog: 321-25-42 (Lot serial: All); Model Catalog: 321-25-38 (Lot serial: All); Model Catalog: 321-25-46 (Lot serial: All); Model Catalog: 321-25-01 (Lot serial: All)
  • Product Description
    MODULAR REVERSE REAMER PILOT TIP;MODULAR REVERSE REAMER STARTER PILOT TIP
  • Manufacturer
    EXACTECH INC.

Manufacturer

EXACTECH INC.
  • Manufacturer Address
    GAINESVILLE
  • Manufacturer Parent Company (2017)
    Exactech Inc.
  • Source
    HC