Events

Recall of Device Recall Ziptight Ankle Syndesmosis Fixation

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
    79973
  • Event Risk Class
    Class 2
  • Event Number
    Z-1915-2018
  • Event Initiated Date
    2017-08-22
  • 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=164064
  • 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
    Fastener, fixation, nondegradable, soft tissue - Product Code MBI
  • Reason
    The product was packaged without the tip protectors.
  • Action
    August 22, 2017 letter to Risk Managers and Surgeons includes the following instructions: Risk Manager Responsibilities: 1. Review this notification and ensure affected personnel are aware of the contents. 2. Assist your Zimmer Biomet sales representative quarantine all affected product. 3. Your Zimmer Biomet sales representative will remove the affected product from your facility. 4. Complete Attachment 1  Certificate of Acknowledgement. a. Return a digital copy to corporatequality.postmarket@zimmerbiomet.com. b. Retain a copy of the Acknowledgement Form with your field action records in the event of a compliance audit of your facilities documentation. 5. If after reviewing this notice you have further questions or concerns please call the customer call center at 1-574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of the call center operating hours will receive a prompt to record a voicemail or be transferred to an on-call representative in the case of an emergency. Alternatively, your questions may be sent by email to corporatequality.postmarket@zimmerbiomet.com. Surgeon Responsibilities: 1. Review this notification for awareness of the contents. 2. There are no specific patient monitoring instructions related to this field action that are recommended beyond your existing follow up schedule. 3. Complete Attachment 1  Certificate of Acknowledgement. a. Return a digital copy to corporatequality.postmarket@zimmerbiomet.com. b. Retain a copy of the Acknowledgement Form with your field action records in the event of a compliance audit of your documentation. 4. If after reviewing the notice you have further questions or concerns please call the customer call center at 1-877-946-2761 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of the call center operating hours will receive a prompt to record a voicemail or be transferred to an on-call representative in the case of an emergenc

Device

Device Recall Ziptight Ankle Syndesmosis Fixation
  • Model / Serial
    Lot #: 058860, 058880, 058890, 058910, 116030, 169780, 169790, 213450, 213480, 374420, 392530, 476670, 503830, 614910, 670640, 728190, 984070, 984080;  UDI #:  (01)00880304476103(17)220523(10)058860,  (01)00880304476103(17)220608(10)058880,  (01)00880304476103(17)220608(10)058890,  (01)00880304476103(17)220608(10)058910,  (01)00880304476103(17)220519(10)116030,  (01)00880304476103(17)220609(10)169780,  (01)00880304476103(17)220608(10)169790,  (01)00880304476103(17)220609(10)213450,  (01)00880304476103(17)220607(10)213480,  (01)00880304476103(17)220319(10)374420,  (01)00880304476103(17)220610(10)392530,  (01)00880304476103(17)220607(10)476670,  (01)00880304476103(17)220608(10)503830,  (01)00880304476103(17)220421(10)614910,  (01)00880304476103(17)220621(10)670640,  (01)00880304476103(17)220606(10)728190,  (01)00880304476103(17)220512(10)984070,  (01)00880304476103(17)220607(10)984080
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide distribution. US nationwide, Argentina, Australia, Canada, Costa Rica, Japan, and Netherlands.
  • Product Description
    Ziptight Ankle Syndesmosis Fixation - Ti, Item # 904759 orthopedic fixation device
  • Manufacturer
    Zimmer Biomet, Inc.

Manufacturer

Zimmer Biomet, Inc.
  • Manufacturer Address
    Zimmer Biomet, Inc., 56 E Bell Dr, Warsaw IN 46582-6989
  • 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