Events

Recall of Device Recall Equinoxe Cage, Glenoid, Alpha, Medium

According to U.S. Food and Drug Administration, this recall involved a device in United States 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
    78903
  • Event Risk Class
    Class 2
  • Event Number
    Z-0415-2018
  • Event Initiated Date
    2017-08-31
  • Event Date Posted
    2018-01-18
  • 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=160831
  • 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
    Prosthesis, shoulder, semi-constrained, metal/polymer cemented - Product Code KWS
  • Reason
    Potentially mislabeled.
  • Action
    Consignees were sent a Recall Notice dated 8/31/2017 by mail informing them of the potential mislabel. The notice requested consignees: Immediately cease distribution/use of this product; Extend information to accounts in possession of the product; Identify and quarantine any subject devices in their inventory; Complete and return Recall Acknowledgement and Recall Inventory Response Forms. For further questions please call (800) 392-2832.

Device

Device Recall Equinoxe Cage, Glenoid, Alpha, Medium
  • Model / Serial
    Catalog #: 314-13-03 Serial Range: 5013020 - 5013049
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide distribution in the states of OH, WI, AZ, GA, VA, CA, OK, MN, TN, ME, CO, SC, FL, AL, and Puerto Rico and country of Switzerland
  • Product Description
    Equinoxe Cage, Glenoid, Alpha, Medium || Product Usage: || The Equinoxe Shoulder System is indicated for use in skeletally mature individuals with degenerative diseases or fractures of the glenohumeral joint where total or hemi- arthroplasty is determined by the surgeon to be the preferred method of treatment.
  • Manufacturer
    Exactech, Inc.

Manufacturer

Exactech, Inc.
  • Manufacturer Address
    Exactech, Inc., 2320 NW 66th Ct, Gainesville FL 32653-1630
  • Manufacturer Parent Company (2017)
    Exactech Inc
  • Source
    USFDA