Events

Safety Alert for Implantable Spinal Fusion Stimulators

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Zimmer Biomet.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2017-05-31
  • Event Date Posted
    2017-05-31
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20170531.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: zimmer biomet implantable spinal fusion stimulators the united states food and drug administration (fda) has issued a medical device safety alert concerning spf plus-mini (60μa/w) & spf spf xl iib implantable spinal fusion stimulators, manufactured by zimmer biomet. the affected devices are identified as follows: serial numbers: spf-xl iib: 224595, 224598, 224607, 224608, 224610, 224613, 224615, 224621, 224622, 224623, 224624, 224625, 224626, 224644, 224649, 224651, 224655, 224656, 224658, 224659, 224666, 224667 spf-plus: 410093, 410094, 410096, 410103, 410111, 410115, 410119, 410148, 410151, 410158, 410171 distribution dates: 28 march 2017 to 6 april 2017 manufacturing dates: 11 october 2016 to 18 january 2017 the manufacturer is recalling the spf plus-mini and spf xl iib implantable spinal fusion stimulators due to higher than allowed levels of potential harmful chemicals, which may be toxic to tissues and organs (cytotoxicity) and that were found during the company's routine monitoring procedure. a cytotoxicity test is a part of the biological evaluation of medical devices to ensure compatibility with the device and the human body. a positive cytotoxicity test (failed result) can indicate that a device contains potential harmful chemicals at amounts or levels that could be dangerous to the patient. the use of affected product may cause serious adverse health consequences, including but not limited to chronic infections, long-term hospitalization due to additional surgical procedures, paralysis, and death. on 20 april 2017, the manufacturer sent an urgent medical device removal notification to all affected users. the notice instructed affected users to: quarantine all affected products. surgeons are reminded that normal clinical monitoring is recommended for 3-6 months post operatively for any patient with the affected devices implanted. product removal is on-going. according to the local supplier, the affected products are not distributed in hong kong. for details, please refer to the fda websites: https://www.Accessdata.Fda.Gov/scripts/ires/index.Cfm#event_77089 https://www.Fda.Gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm561044.Htm https://www.Fda.Gov/medicaldevices/safety/listofrecalls/ucm561004.Htm if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 31 may 2017.

Device

Implantable Spinal Fusion Stimulators
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Zimmer Biomet Implantable Spinal Fusion Stimulators
  • Manufacturer
    Zimmer Biomet

Manufacturer

Zimmer Biomet
  • 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
    DH