Events

Recall of Device Recall Anatomical Shoulder" Domelock

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Zimmer Gmbh.

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
    74206
  • Event Risk Class
    Class 2
  • Event Number
    Z-2003-2016
  • Event Initiated Date
    2016-05-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-10-31
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=146784
  • 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, shoulder, semi-constrained, metal/polymer cemented - Product Code KWS
  • Reason
    In some cases it has been difficult or not possible to disassemble the adjusted dome centric from the as humeral rasp after initial positioning of the as humeral trial head which resulted in the whole construct of the dome centric with the still assembled as humeral rasp taken out of the humeral canal. this could cause a delay in surgery time or the surgeon could decide to close the wound without finishing the surgery, increasing the infection risk or second use of anesthesia necessary.
  • Action
    Zimmer Biomet sent an URGENT MEDICAL DEVICE RECALL  LOT SPECIFIC notification dated May 17, 2016, to all affected consignees via courier with instructions for identifying and returning the affected product. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Consignees were instructed to review the notification and ensure affected personnel were aware of the contents. Assist their Zimmer Bioment sales representative with the quarantine of any affected product from the table above. Complete the Certificate of Acknowledgement Form and return to corporatequality.postmarket@zimmerbiomet.com. If after reviewing this notification consignees have further questions or concerns please call the customer call center at 1- 800-348-2759 between 8:00 am and 8:00 pm EST.

Device

Device Recall Anatomical Shoulder" Domelock
  • Model / Serial
    Item Number: 01.04227.005 Lot Numbers: 2792457 2794578 2812029 2817212 2844463 2794576 2794579 2815118 2817213 2847568 2794577 2794580 2815119 2832862
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution to AZ, CA, CO, GA, IL, KS, KY, MA, MD, MO, OH, PA, TN, and TX.
  • Product Description
    Dome Centric component (Reference 01.04227.005) from the Anatomical Shoulder (AS) System 2.0. || The Dome Centric connects the Humeral Stem to the Humeral Head and allows setting an inclination and retroversion positioning. || The Anatomical Shoulder System is intended for long-term implantation into the human shoulder joint in primary or revision, total or hemi shoulder arthroplasty. The system is intended to relieve pain and restore function in patients with adequate bone stock to support the prosthesis.
  • Manufacturer
    Zimmer Gmbh

Manufacturer

Zimmer Gmbh
  • Manufacturer Address
    Zimmer Gmbh, Sulzer Allee 8, Winterthur Switzerland
  • 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