Events

Recall of DAL-RO ABUTMENT SET

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by BIOMET 3I ALSO TRADING AS IMPLANT INNOVATIONS 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
    23265
  • Event Risk Class
    II
  • Event Initiated Date
    2015-11-30
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    During the investigation of a customer complaint two packages of locator abutments (loa002) were confirmed to have not been sealed during manufacturing.

Device

DAL-RO ABUTMENT SET
  • Model / Serial
    Model Catalog: DRH40 (Lot serial: >10 CONTACT MFR); Model Catalog: DRH20 (Lot serial: >10 CONTACT MFR); Model Catalog: THRC4 (Lot serial: >10 CONTACT MFR); Model Catalog: IOLHC (Lot serial: >10 CONTACT MFR); Model Catalog: CA002 (Lot serial: >10 CONTACT MFR); Model Catalog: >10 CONTACT MFR (Lot serial: >10 CONTACT MFR); Model Catalog: MHC33 (Lot serial: >10 CONTACT MFR); Model Catalog: LORHK (Lot serial: >10 CONTACT MFR); Model Catalog: LOAH (Lot serial: >10 CONTACT MFR); Model Catalog: OSO60 (Lot serial: >10 CONTACT MFR); Model Catalog: OSO40 (Lot serial: >10 CONTACT MFR); Model Catalog: WCA53 (Lot serial: >10 CONTACT MFR); Model Catalog: WCA52 (Lot serial: >10 CONTACT MFR); Model Catalog: WCA51 (Lot serial: >10 CONTACT MFR); Model Catalog: DRTH (Lot serial: >10 CONTACT MFR); Model Catalog: ILOA006 (Lot serial: >10 CONTACT MFR); Model Catalog: ILOA005 (Lot serial: >10 CONTACT MFR); Model Catalog: ILOA004 (Lot serial: >10 CONTACT MFR); Model Catalog: ILOA003 (Lot serial: >10 CONTACT MFR); Model Catalog: ICA0
  • Product Description
    DAL-RO ABUTMENT SET
  • Manufacturer
    BIOMET 3I ALSO TRADING AS IMPLANT INNOVATIONS INC.

Manufacturer

BIOMET 3I ALSO TRADING AS IMPLANT INNOVATIONS INC.
  • Manufacturer Address
    PALM BEACH GARDENS
  • 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
    HC