Events

Recall of Device Recall Farabeuf Clamp for 3.5mm Screws PRO

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Stryker 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
    80198
  • Event Risk Class
    Class 2
  • Event Number
    Z-2244-2018
  • Event Initiated Date
    2018-05-04
  • 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=164838
  • 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
    Clamp - Product Code HXD
  • Reason
    Laser etching which indicates whether the device is in compression or distraction mode appears to be on the wrong side of the lever arm.
  • Action
    On May 8, 2018, URGENT PRODUCT RECALL and BUSINESS REPLY notices were issued to U.S.A customers via UPS. Customers are encouraged to take the following actions: 1. Inform individuals within your organization who need to be aware of this device recall. 2. Immediately check all stock areas and/or operating room storage to determine if any devices from the affected product list are at your facility. Response is required by submitted the completed response form via email to: StrykerOrtho6487@stericycle.com, even though you may not have any physical inventory on site anymore. 3. Quarantine and discontinue use of the recalled devices. 4. Maintain awareness of this notice internally until all required actions have been completed within your facility 5. Inform Stryker if any of the subject devices have been distributed to other organizations. a) Please provide contact details so that Stryker can inform the recipients appropriately. b) If you are a Distributor, note that you are responsible for notifying your affected customers. Customers with questions may call 201-831-5000.

Device

Device Recall Farabeuf Clamp for 3.5mm Screws PRO
  • Model / Serial
    Lot # 04857V
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    AR, CA, ID, IL, MD, MI, NJ, NY, OK, SD & TX
  • Product Description
    Farabeuf Clamp for 3.5mm Screws PRO, Catalog # 705463
  • Manufacturer
    Stryker GmbH

Manufacturer

Stryker GmbH
  • Manufacturer Address
    Stryker GmbH, Bohnackerweg 1, Selzach Switzerland
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    USFDA