Events

Recall of Device Recall Zimmer Selftapping bone screw

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-1684-2016
  • 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=145990
  • 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, semi-constrained, metal/polymer, porous uncemented - Product Code LPH
  • 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 Selftapping bone screw
  • Model / Serial
    LOTS: 63284570 63284572 63284573 63187350 63225662 63272712 63296123 63301504 63204283 63209528 63259476 63257719
  • 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
    Trilogy self-tapping bone screw || Bone screw 4.5x25 selftap 00625004525 || Bone screw 4.5x50 selftap 00625004550 || Bone screw 6.5x15 selftap 00625006515 || Bone screw 6.5x20 selftap 00625006520 || Bone screw 6.5x25 selftap 00625006525 || Bone screw 6.5x30 selftap 00625006530
  • 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