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-1677-2016
  • 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=145971
  • 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: 63303573 63282072 63303577 63303574 63296633 63295456 63296634 63198636 63295464 63296636 63296638 63301486 63301487 63301489 63296639 63248519 63298802 63298803 63287869 63248522 63317364 63317363 63248525 63298795 63320881 63287871 63317168 63248527 63317167 63287874 63248531 63248532 63248535 63248537 63293690 63293693 63293694 63305250 63298784 63284871 63298783 63249226 63305251 63312141
  • 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) || 4.0 mm Cancellous Screw Fully Threaded, 12 mm Length 47484001200 || 4.0 mm Cancellous Screw Fully Threaded, 14 mm Length 47484001400 || 4.0 mm Cancellous Screw Fully Threaded, 16 mm Length 47484001600 || 4.0 mm Cancellous Screw Fully Threaded, 18 mm Length 47484001800 || 4.0 mm Cancellous Screw Fully Threaded, 20 mm Length 47484002000 || 4.0 mm Cancellous Scrwe Fully Threaded, 22 mm Length 47484002200 || 4.0 mm Cancellous Screw Fully Threaded, 26 mm Length 47484002600 || 4.0 mm Cancellous Screw Fully Threaded, 30 mm Length 47484003001 || 4.0 mm Cancellous Screw Fully Threaded, 32 mm Length 47484003200 || 4.0 mm Cancellous Screw Fully Threaded, 36 mm Length 47484003600 || 4.0 mm Cancellous Screw Fully Threaded, 40 mm Length 47484004000 || 4.0 mm Cancellous Screw Fully Threaded, 45 mm Length 47484004500 || 4.0 mm Cancellous Screw Fully Threaded, 50 mm Length 47484005000 || 4.0 mm Cancellous Screw Fully Threaded, 55 mm Length 47484005500 || 4.0 mm Cancellous Screw Fully Threaded, 60 mm Length 47484006000 || 4.5 mm Cortical Screw SelfTapping, 16 mm Length 47484501601 || 4.5 mm Cortical Screw SelfTapping, 18 mm Length 47484501801 || 4.5 mm Cortical Screw Self-Tapping, 20 mm Length 47484502001 || 4.5 mm Cortical Screw Self-Tapping, 22 mm Length 47484502201 || 4.5 mm Cortical Screw SelfTapping, 24 mm Length 47484502401 || 4.5 mm Cortical Screw SelfTapping, 26 mm Length 47484502601 || 4.5 mm Cortical Screw SelfTapping, 28 mm Length 47484502801 || 4.5 mm Cortical Screw SelfTapping, 34 mm Length 47484503401 || 4.5 mm Cortical Screw SelfTapping, 38 mm Length 47484503801 || 4.5 mm Cortical Screw SelfTapping, 40 mm Length 47484504001 || 4.5 mm Cortical Screw SelfTapping, 42 mm Length 47484504201 || 4.5 mm Cortical Screw SelfTapping, 54 mm Length 47484505401 || 4.5 mm Cortical Screw Self-Tapping, 58 mm Length 47484505801 || 4.5 mm Cortical Screw SelfTapping, 64 mm Length 47484506401 || 4.5 mm Cortical Screw SelfTapping, 66 mm Length 47484506601 || 4.5 mm Cortical Screw SelfTapping, 68 mm Length 47484506801 || 4.5 mm Cortical Screw SelfTapping, 70 mm Length 47484507001 || 6.5 mm Cancellous Screw Fully Threaded, 45 mm Length 47486504500 || 6.5 mm Cancellous Screw Fully Threaded, 55 mm Length 47486505500 || 6.5 mm Cancellous Screw Fully Threaded, 60 mm Length 47486506000 || 6.5 mm Cancellous Screw, 32 mm Thread Length, 60 mm Length 47486506002 || 6.5 mm Cancellous Screw Fully Threaded, 65 mm Length 47486506500 || 6.5 mm Cancellous Screw, 32 mm Thread Length, 65 mm Length 47486506502 || 6.5 mm Cancellous Screw Fully Threaded, 70 mm Length 47486507000 || 6.5 mm Cancellous Screw, 16 mm Thread Length, 80 mm Length 47486508001 || 6.5 mm Cancellous Screw, 32 mm Thread Length, 80 mm Length 47486508002 || 6.5 mm Cancellous Screw, 32 mm Thread Length, 85 mm Length 47486508502
  • 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