Events

Recall of iBalance(R) UKA, Femoral Cemented, Size 3, Left Medial/Right LATERAL

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Arthrex, 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
    78297
  • Event Risk Class
    Class 2
  • Event Number
    Z-0095-2018
  • Event Initiated Date
    2017-10-03
  • Event Status
    Completed
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=159082
  • 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, knee, femorotibial, non-constrained, cemented, metal/polymer - Product Code HSX
  • Reason
    Arthrex part number ar-501-uflc, size 3, batch 10123297, has the incorrect part number ar-501 ¿ufra, size 1 printed on the patient label inside the box.
  • Action
    Arthrex sent an Urgent Medical Device Voluntary Recall letter on October 3, 2017. The letter requested the following: "Immediately discontinue use of these devices. In order to receive credit for the returned devices, please follow the steps below: 1) Review this notification and ensure affected personnel are aware of the contents. 2) Immediately identify and return all the indicated product/batch numbers you have in inventory. Call Arthrex Field Logistics Service at 1-866¿612-7899 for a returned goods authorization (RGA) and product return instructions. Email: FLS@Arthrex.com." Customers with questions were instructed to call Product Surveillance at 866-267-9138 or by email to commplaints@arthrex.com.

Device

iBalance(R) UKA, Femoral Cemented, Size 3, Left Medial/Right LATERAL
  • Model / Serial
    batch 10123297
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - US including SD, NV, NC, CA, MD, AZ, CA, LA, FL, PA, TX, NY, GA, and Internationally to GERMANY, POLAND
  • Product Description
    iBalance(R) UKA, Femoral Cemented, Size 3, Left Medial/Right LATERAL, REF AR 501-UFLC, QTY 1, Rx ONLY, STERILE R, Arthrex, Inc., Naples, FL || Indicated for use in uni-compartmental knee arthroplasty as a result of: 1. Moderately disabling joint disease of the knee resulting from painful osteoarthritis or posttraumatic arthritis. 2. Correction of functional deformity. 3. Revision of previous unsuccessful uni-compartmental knee replacement or other procedure. 4. As an alternative to tibial osteotomy in patients with uni-compartmental osteoarthritis.
  • Manufacturer
    Arthrex, Inc.

Manufacturer

Arthrex, Inc.
  • Manufacturer Address
    Arthrex, Inc., 1370 Creekside Blvd, Naples FL 34108-1945
  • Manufacturer Parent Company (2017)
    Arthrex, Inc.
  • Source
    USFDA