Events

Recall of Device Recall Verso Shoulder Forked Retractor

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Biomet, 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
    73173
  • Event Risk Class
    Class 2
  • Event Number
    Z-1093-2016
  • Event Initiated Date
    2016-02-16
  • Event Date Posted
    2016-03-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-05-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143316
  • 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
    Retractor - Product Code GAD
  • Reason
    Zimmer biomet inc. verso shoulder forked retractor (comprehensive instrumentation 2 prong retractor) supplied by kirkstall precision was made according to the w1.4034 (420 stainless) which does not conform to 420 s29 indicated on the print. all units manufactured to date were manufactured using 420 stainless. therefore, all lots of pn: 402852 are considered in scope.
  • Action
    Zimmer Biomet sent an Urgent Medical Device Recall letter dated February 16, 2016, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the customer. The following actions are REQUIRED: Immediately locate and remove the identified device(s) listed below from circulation. Carefully follow the instructions on the enclosed Response Form. Email a copy of the response form to CPWARFieldAction@zimmerbiomet.com prior to return of product. Use priority carrier for your shipment. If you have further distributed this product, you MUST notify hospital personnel of this action via the enclosed Dear Risk/Recall Manager notice. This letter MUST be given to hospital personnel responsible for receiving recall notices. However, you are charged with the location and return of these products. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA: Questions related to this notice should be directed to (574) 372-1570, Monday through Friday, 8 a.m. to 5 p.m.

Device

Device Recall Verso Shoulder Forked Retractor
  • Model / Serial
    all lots of PN: 402852
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US including CA, NY, VA, IL, IN, SC, NC, AR, MO, ND, AL, PA, MI, WA, OR, LA, FL, GA, OH, KS, KY, TX, MA, AZ, NJ, UT, IO, NM, WV, MS, NE, and MD OUS: Australia, Chile, Columbia, Costa Rica, Argentina, Korea, Japan, Panama, Malaysia, Puerto Rico, Canada, and The Netherlands.
  • Product Description
    Verso Shoulder Forked Retractor (Comprehensive Instrumentation 2 Prong Retractor) || Biomet Comprehensive Reverse Shoulder products are indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary. The Comprehensive Reverse Shoulder is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.
  • Manufacturer
    Biomet, Inc.

Manufacturer

Biomet, Inc.
  • Manufacturer Address
    Biomet, Inc., 56 E Bell Dr, Warsaw IN 46582-6989
  • Manufacturer Parent Company (2017)
    Zimmer Biomet Holdings
  • Manufacturer comment
    “The safety of patients has always been, and continues to be, Zimmer Biomet’s top priority and it is our honor to be a leader in this industry for the past 90 years,” Zimmer Biomet told ICIJ in a statement. “We adhere to strict regulatory standards, and work closely with the FDA and all applicable regulatory agencies in each of our regions as part of our commitment to operating a first-rate quality management system across our global manufacturing network. The company added that it is focused on staying at the forefront of innovation and doing right by the millions of patients who rely on the company’s products.
  • Source
    USFDA