Events

Recall of Device Recall ECT Internal Fracture Fixation Drill Bits

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
    77417
  • Event Risk Class
    Class 2
  • Event Number
    Z-3169-2017
  • Event Initiated Date
    2017-05-22
  • Event Date Posted
    2017-09-22
  • 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=158395
  • 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
    Instrument, surgical, orthopedic, ac-powered motor and accessory/attachment - Product Code HWE
  • Reason
    A raw material anomaly was discovered during inspection at zimmer biomet, and an investigation by the supplier determined that 4 lots of raw material could have similar anomalies. the anomaly has the potential to be on or below the surface and can increase the risk of instrument fracture. accordingly, all products manufactured with the affected raw material are being removed from the field.
  • Action
    On 5/22/2017, Zimmer Biomet distributed Urgent Medical Device Recall notices to their customers and distributors. On 12/19/2017, Zimmer Biomet sent Urgent Medical Device Recall notices to their customers due to a recall expansion involving one (1) lot for product # 20. Customers are advised to review the notice and ensure that affected personnel are aware of the contents. All stock should be inspected and product quarantined. A Zimmer Biomet sales representative will remove the affected product from your facility. Customers should complete and return the Certificate of Acknowledgement via email to: corporatequality.postmarket@zimmerbiomet.com and retain the copy for your files. Customers with questions may call the customer call center at 574-371-3071, Monday through Friday 8 am - 5 pm, EST. *For Distributors Your Responsibilities include the following: 1. Review this notification and ensure affected team members are aware of the contents. 2. Immediately locate and quarantine affected product in your inventory. 3. Complete the Certification of Acknowledgement portion of Attachment 1  Inventory Return Certification Form. a. Return a digital copy to corporatequality.postmarket@zimmerbiomet.com within three (3) days. 4. Immediately return all affected product from your distributorship and affected hospitals within your territory along with a completed Attachment 1  Inventory Return Certification Form to Zimmer Biomet. a. For each return, send a copy of the completed acknowledgement form via email to: corporatequality.postmarket@zimmerbiomet.com. b. Include a hardcopy of Attachment 1 with your shipment for immediate processing. c. Include a copy of Attachment 3  Certificate of Sterilization with returned instruments. d. Mark the outside of the returns box(es) clearly with FIELD ACTION. 5. Note that any hospitals that received direct shipments of this product from Zimmer Biomet will be sent a copy of the Risk Manager Field Action Notice direc

Device

Device Recall ECT Internal Fracture Fixation Drill Bits
  • Model / Serial
    Lot Numbers: 63556699, 63556701, 63593922, 63616886, 63630279,  63641603, 63358167, 63372864, 63372865, 63377514, 63377516,  63415331, 63426482, 63431757, 63457850, 63457853, 63457856,  63469884, 63474434, 63479002, 63479004, 63479006 & 63524437.
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide in USA; Internationally to: Australia, Brazil, Canada, China, El Salvador, Germany, Guatemala, India, Japan, Panama, Malaysia, Mexico, Netherlands, South Korea, Singapore, Taiwan & Trinidad.
  • Product Description
    ECT Internal Fracture Fixation Drill Bits 2.7 mm Diameter (.106 Inch), Item Number/EDI 00231802706, Nonsterile
  • 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