Events

Recall of Device Recall Avenir Mller Stem

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
    74693
  • Event Risk Class
    Class 2
  • Event Number
    Z-2292-2016
  • Event Initiated Date
    2016-06-30
  • Event Date Posted
    2016-07-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-03-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148232
  • 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/ceramic/polymer, cemented or non-porous, uncemented - Product Code LZO
  • Reason
    Product mix-up. the avenir m¿ller stem 6 lateral uncemented might be placed in the packaging of the avenir m¿ller stem 4 standard uncemented and vice versa. potential for delay in surgery, and/or potential for use of incorrect implant which may in turn lead dismetry in patient and possibly the need for revision.
  • Action
    Zimmer Biomet sent an Urgent Medical Device Recall letter dated June 30, 2016 to all affected customers via courier. 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. Customers were instructed to review the notification immediately and ensure affected personnel are aware of the contents and assist Zimmer Biomet sales representative with the quarantine of any affected device. Your Zimmer Biomet sales representative will remove any affected device. Customers were also instructed to complete the Certification of Acknowledgement form and return to corporatequality.postmarket@zimmerbiomet.com. Customers with further questions or concerns were instructed to contact the customer call center at 1-800-348-2759 between 8:00 am and 8:00 pm EST. For questions regarding this recall call 800-348-2759.

Device

Device Recall Avenir Mller Stem
  • Model / Serial
    Item Name: Avenir M¿ller Stem 4 Standard Item Number: 01.06010.004 Lot Number: 4022860  Item Name: Avenir M¿ller Stem 6 Lateral Item Number: 01.06010.106 Lot Number: 4023094
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution to OH and NM
  • Product Description
    Avenir M¿ller Stem 4 Standard || Avenir M¿ller Stem 6 Lateral || Hip joint metal/ceramic/polymer semi-constrained cemented or || nonporous uncemented prosthesis || Intended Use: " Advanced wear of the joint due to degenerative, post-traumatic or rheumatic diseases. " Failed previous hip surgery including joint reconstruction (osteotomy), arthrodesis, hemiarthroplasty or total hip replacement (THR). " Acute traumatic fracture of the femoral head or neck " Avascular necrosis of the femoral head. " Avenir Moller Stems are for cementless use only.
  • 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