Events

Recall of Device Recall Set Screw

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Biomet Spine, LLC.

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
    70383
  • Event Risk Class
    Class 2
  • Event Number
    Z-1146-2015
  • Event Initiated Date
    2012-11-30
  • Event Date Posted
    2015-02-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-05-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=133411
  • 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
    Orthosis, spinal pedicle fixation, for degenerative disc disease - Product Code NKB
  • Reason
    Biomet spine llc is recalling the set screw 5.5 mm rod due to the set screw being out of specification.
  • Action
    Biomet Spine LLC (formerly Lanx) sent an Urgent Recall Notification letter to affected customers. The letter identified the affected product, problem, and actions to be taken. For questions contact Lanx Customer Service.

Device

Device Recall Set Screw
  • Model / Serial
    LOT Numbers: L561968 and L570545 Product Code: 77031600
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - US Nationwide in the states of: AZ, CA, CO, CT, FL, GA, HI, IA, ID, IN, KY, LA, MA, MD, MI, MO, NC, NE, NY, OH, OR, PA, TN, TX, VA, WI. and the countries of: Italy, and Mexico.
  • Product Description
    Set Screw 5.5 mm Rod - Model #7703-1600. || Product Usage: The titanium alloy set screw is used to seat a 5.5 mm titanium alloy, commercially pure titanium or cobalt chrome rod into a pedicle screw tulip in order to create a spinal fixation construct. The Set Screw is provided to the user non-sterile and is used across three Biomet Spine product lines; Silverton Spinal Fixation System (Silverton), Silverton-D Spinal Fixation System (Silverton-D) and Telluride Minimally Invasive Spinal Fixation System (Telluride). || The primary packaging for the Set Screws is an aluminum sterilization case that holds both implants and instruments used collectively as part of a system. Additionally, Set Screws can be packaged in a heat sealed polypropylene bag for single device distribution.
  • Manufacturer
    Biomet Spine, LLC

Manufacturer

Biomet Spine, LLC
  • Manufacturer Address
    Biomet Spine, LLC, 310 Interlocken Pkwy Ste 120, Broomfield CO 80021-3464
  • 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