Events

Recall of Device Recall Locking Cortical Screw

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
    67142
  • Event Risk Class
    Class 2
  • Event Number
    Z-0716-2014
  • Event Initiated Date
    2013-12-19
  • Event Date Posted
    2014-01-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-07-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124768
  • 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
    Plate, fixation, bone - Product Code HRS
  • Reason
    3.5mmx38mm locking cortical screw, implants are being recalled since an investigation identified that a 3.5mmx28mm cortical locking screw is labeled as a 3.5mmx38mm cortical locking screw.
  • Action
    URGENT MEDICAL DEVICE RECALL notices were sent to all consignees on December 19, 2013. Distributors who have affected hospitals in their regions were notified and provided with a copy of the notice that went to each hospital. Consignees are being contacted on an individual basis in an attempt to reconcile the product 100%. Fax back forms were provided to all consignees in order for Biomet to track returns. Non-responders will be contacted on an individual basis.

Device

Device Recall Locking Cortical Screw
  • Model / Serial
    Catalog Number: 816135038 (8161-35-038) Lot Number Identification: RM244D
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US Distribution including states of: AZ, CA, GA, IL, KY, MI, NC, NH, NY, OH, PA, SD, TX, UT, and VA.
  • Product Description
    Locking Cortical Screw || 3.5mmX38mm || REF 8161-35-038
  • 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