Events

Recall of Device Recall G7 Positioning Guide Rod

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
    68310
  • Event Risk Class
    Class 2
  • Event Number
    Z-1837-2014
  • Event Initiated Date
    2014-05-07
  • Event Date Posted
    2014-06-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-10-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127364
  • 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, hip, constrained, cemented or uncemented, metal/polymer, + additive - Product Code PBI
  • Reason
    Guide rod may fracture during impaction of the acetabular shell and be retained in the inserter or the patient and could result in a delay in surgery.
  • Action
    The firm issued the following notice on May 7, 2014: URGENT MEDICAL DEVICE RECALL NOTICE: This notification is to inform you of an Urgent Medical Device Recall initiated by Biomet Orthopedics ("Biomet") which involves Part Numbers: 110003458 G7 Positioning Guide Rod and 110003500 G7 Positioning Guide Post. These instruments have been consigned and/or invoiced to your account. Biomet has initiated this action following an investigation which identified that positioning guide rod may fracture during impaction of the acetabula shell. If the positioning guide rod fractures, then the positioning guide post may become stuck to the insertion handle. There is no adverse health outcome expected for the patient. This action requires the immediate location and discontinued use of the product and its return to Biomet. The following actions are REQUIRED: Immediately locate and remove the identified device(s) listed below from circulation. Carefully follow the instructions on the enclosed "FAX Back Response Form. Fax a copy of the Response Form to 574-372-1683 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.

Device

Device Recall G7 Positioning Guide Rod
  • Model / Serial
    PN:110003458. Lots 424960, ZB130702, ZB130703, ZB130704, ZB130705, ZB130701, ZB131201, 360877, 377304 and ZB140201.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution-USA (nationwide) and the countries of Canada, Netherlands, New Zealand, and Japan.
  • Product Description
    G7 Acetabular System Positioning Guide Rod, orthopedic surgical instrument for hip prosthesis PN 110003458.
  • 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