Events

Recall of Device Recall Smooth Guide Wire Bullet Tip, 3.0 mm Diameter, 100 cm Length; Item Number: 47225500801

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Zimmer 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
    79681
  • Event Risk Class
    Class 2
  • Event Number
    Z-1473-2018
  • Event Initiated Date
    2018-03-26
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162979
  • 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
    Orthopedic manual surgical instrument - Product Code LXH
  • Reason
    Potential failure of sterile packaging seal.
  • Action
    Zimmer Biomet will conduct this recall to distributors and hospital risk managers that have consigned inventory or inventory within their territory, as well as distributors that have accounts in their territory that received a direct sale of affected products. Affected products that remain in consignment will be referred to as fielded inventory throughout the remainder of this recall strategy. All distributors will be notified via email. Hospital risk managers, as well as distributors, with direct sales and/or fielded inventory, will be notified via courier. Notification letters were sent to customers on March 26, 2018. " Distributors will be sent a letter identifying the issue and their responsibilities. These responsibilities include locating and removing the product in their territory, as well as identifying hospitals who have fielded inventory. " Distributors will return on-hand product to Zimmer Biomet and ensure all affected fielded inventory is accounted for using the form provided in the letter. " Hospital risk managers will be provided with a letter identifying the issue and their responsibilities. These responsibilities include: o Assisting the Zimmer Biomet sales representative with the quarantine of fielded inventory and completion and return of the Attachment 1 form. o Complete and return Attachment 1 (Acknowledgement of Responsibility) to email address provided.

Device

Device Recall Smooth Guide Wire Bullet Tip, 3.0 mm Diameter, 100 cm Length; Item Number: 4722550...
  • Model / Serial
    Lot Numbers:  63619923 63625354 63625355 63625356 63631736 63631737 63638178 63638179 63638180 63638181 63639395 63639396 63639397 63639398 63639399 63639401 63645656 63645657 63645658 63645659 63648799 63648801 63648802 63648803 63650117 63650118 63651633 63651634 63651635 63656843 63662543 63662544 63662545 63662546 63662547 63668702 63668703 63668721 63675676 63675677 63681732 63681733 63681734 63681735 63690182 63690183 63690184 63690185 63696959 63696960 63696961 63705243 63705244 63705245 63705246 63709167 63709168 63709169 63709170 63715687 63715688 63721372 63721373 63721374 63721375 63731172 63731173 63731174 63731175 63733047 63733048 63764548 63771161 63771162 63780124 63780125 63781880 63803593 63812301 63796536 63796537
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US Nationwide and the following countries: Brazil, Singapore, Canada, Australia, Japan, Malaysia, Chile, Netherlands, Trinidad
  • Product Description
    Smooth Guide Wire Bullet Tip || 3.0 mm Diameter, 100 cm Length; Item Number: 47-2255-008-01
  • Manufacturer
    Zimmer Biomet, Inc.

Manufacturer

Zimmer Biomet, Inc.
  • Manufacturer Address
    Zimmer Biomet, Inc., 1800 W Center St, Warsaw IN 46580-2304
  • 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