Events

Recall of Device Recall Zimmer Plates and Screws

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Zimmer Manufacturing B.V..

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
    73981
  • Event Risk Class
    Class 2
  • Event Number
    Z-1673-2016
  • Event Initiated Date
    2016-05-04
  • Event Date Posted
    2016-05-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-07-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=145820
  • 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
    Screw, fixation, bone - Product Code HWC
  • Reason
    A small hole may be present in the inner tray of specific lots of sterile hip and trauma implant screws.
  • Action
    All distributors will be notified via electronic mail. Distributors with affected lots will also be notified via courier. Hospitals risk managers and surgeons will be notified via recall notification letter, dated May 4, 2016.

Device

Device Recall Zimmer Plates and Screws
  • Model / Serial
    LOTS: 63252354 63283819 63308551 63252355 63312340 63252350 63283820 63243831
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide distribution. US nationwide, Korea, Japan, Argentina, Brazil, Singapore, Taiwan, China, El Salvador, Australia, India, Hong Kong, Chile, Germany, Italy, France, Spain, UK, Sweden, Canada.
  • Product Description
    Zimmer Plates and Screws (ZPS) || 3.5 mm Cortical Screw SelfTapping, 10 mm Length 47483501001 || 3.5 mm Cortical Screw SelfTapping, 14 mm Length 47483501401 || 3.5 mm Cortical Screw SelfTapping, 16 mm Length 47483501601 || 3.5 mm Cortical Screw SelfTapping, 24 mm Length 47483502401 || 3.5 mm Cortical Screw SelfTapping, 30 mm Length 47483503001 || 3.5 mm Cortical Screw SelfTapping, 40 mm Length 47483504001 || 3.5 mm Cortical Screw SelfTapping, 75 mm Length 47483507501
  • Manufacturer
    Zimmer Manufacturing B.V.

Manufacturer

Zimmer Manufacturing B.V.
  • Manufacturer Address
    Zimmer Manufacturing B.V., Turpeaux Industrial Park Rd 1 km 123.4, Mercedita PR 00715
  • 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