Events

Recall of Device Recall FPS 35mm x 3.5 mm nonlocking screw

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Ortho Solutions 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
    74849
  • Event Risk Class
    Class 2
  • Event Number
    Z-2835-2016
  • Event Initiated Date
    2016-07-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-10-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148595
  • 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
    Screw, fixation, bone - Product Code HWC
  • Reason
    Mislabeling of a single batch of fps 3.5 x 35 mm locking screw as being non-locking screws.
  • Action
    Ortho Solutions sent a "Field Safety Notice" letter dated July 21, 2016 to their affected customers. The letter identify the Solutions Business Development Manager will contact the customer to arrange for the isolation and removal of the unused product from their inventory. Replacement product will be provided. The customer was advised to passed on the "Field Safety Notice" to all who need to be aware within their organization and to any organization to which their have further distributed or transferred the affected screw. Upon removal of the affected device, customers are asked to please sign and return the "Field Safety Corrective Action Declaration Form", by which to confirm they have received the "Field Safety Notice" and that they declare that the required recall has been completed at their hospital. For further questions, call (201) 258-7305.

Device

Device Recall FPS 35mm x 3.5 mm nonlocking screw
  • Model / Serial
    Part number - OS326835 Lot number: 10100/269A12-68051
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US Distribution
  • Product Description
    FPS 35mm x 3.5 mm non-locking screw
  • Manufacturer
    Ortho Solutions Inc

Manufacturer

Ortho Solutions Inc
  • Manufacturer Address
    Ortho Solutions Inc, 330 Franklin Tpke, Mahwah NJ 07430-3524
  • Manufacturer Parent Company (2017)
    Ortho Solutions Inc.
  • Source
    USFDA