Events

Recall of Device Recall Stright Ringloc Button Latch Inserter Handle

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
    64354
  • Event Risk Class
    Class 2
  • Event Number
    Z-0925-2013
  • Event Initiated Date
    2013-02-05
  • Event Date Posted
    2013-03-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-09-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115921
  • 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
    Orthopedic manual surgical instrument - Product Code LXH
  • Reason
    The straight ringloc button latch inserter handle may have been manufactured at the higher end of the tolerance causing interference with the ringloc cup. the inserter handle may lock onto the cup during impaction. if alternative inserters are not available this could cause a surgical delay greater than 30 minutes.
  • Action
    BIOMET sent an Urgent Recall Notice beginning February 13, 2013, to all affected customers. The notice included possible adverse events and directions to locate and remove identified devices by returning a Fax Back Response Form to 574-372-1683 and obtaining an RGA # prior to return of product to Biomet, Inc. 56 East Bell Drive Warsaw, IN 46580. Questions should be directed to 574 372-1570 M-F, 8 a.m.-5.p.m. For questions regarding this recall call 574-267-6639, ext 1676.

Device

Device Recall Stright Ringloc Button Latch Inserter Handle
  • Model / Serial
    Catalog Number 5313152 Lot 153880,153930, 415500, 648010
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - No USA distribution -Internationally to Canada, Japan, and Chile
  • Product Description
    REF S313152 Straight Acetabular Inserter Handle Ringloc || non-sterile || Orthopedic manual surgical instrument
  • 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