Events

Recall of Device Recall Arthrex Deltoid Ligament Reconstruction Implant System

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
    73579
  • Event Risk Class
    Class 2
  • Event Number
    Z-1360-2016
  • Event Initiated Date
    2016-01-11
  • 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=144510
  • 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
    Plate, fixation, bone - Product Code HRS
  • Reason
    Potential for a component contained in the implant system to be non-sterile.
  • Action
    On 01/22/2016, all distributors and end user facilities were sent an Urgent Medical Device Voluntary Recall letter by Arthrex, Inc. The firm is voluntarily recalling and replacing the referenced device. Immediately discontinue distributing and use of the indicated product and return to Arthrex. Additionally the Recall Acknowledgement of Receipt card should be completed and returned. Contact Customer Service at 800-934-4404 for replacement and return information.

Device

Device Recall Arthrex Deltoid Ligament Reconstruction Implant System
  • Model / Serial
    Unique Device Identifier: 00888867131446; Catalog No.: AR-8918CP; Batch No.: 10020303.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Distributed to the states of AR, AZ, CA, CO, FL, IL, IN, KS, KY, LA, MD, MO, NC, NJ, NV, NY, OH, PA, SD, TN, TX, and WI.
  • Product Description
    Arthrex Deltoid Ligament Reconstruction Implant System. || Intended as a fixation post, a distribution bridge or for distributing suture tension over areas of ligament or tendon repair utilizing titanium buttons.
  • 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