Events

Recall of Device Recall UltOS 3.5mm locking screw (12mm to 50mm)

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
    71899
  • Event Risk Class
    Class 2
  • Event Number
    Z-0026-2016
  • Event Initiated Date
    2015-07-14
  • Event Date Posted
    2015-10-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-04-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139303
  • 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
    Ortho solutions inc is initiating a recall on behalf of ultos 3.5mm locking screw. the locking thread feature of the screw was not manufactured to specification. as a consequence there is a risk that a screw may not lock onto the plate at the time of primary insertion into the plate and the bone. in the event of this occurring the non functioning screw would need to be replaced with an alternativ.
  • Action
    The firm, Ortho Solutions Group, sent an "Urgent Medical Device Recall" notifications and "Effectiveness or Recall Declaration Forms" dated 14 July 2015. The notification informed the consignee of the issue, clinical risks, how to identify the affected product, and the actions the consignees were requested to take. Requested actions included reviewing product on-hand, ceasing distribution of affected product and arrangement for product to be returned to Ortho Solutions, Inc. within 2 working days. Consignees were also requested to fill out the Recall Declaration Form and return it to Ortho Solutions, Inc. via fax to: 201-335-0759 by 16 July 2015. If you should have any queries relating to this matter or require any additional information, contact General Manager at 201-906-6175.

Device

Device Recall UltOS 3.5mm locking screw (12mm to 50mm)
  • Model / Serial
    Part Number (Lot Number) infomration is as follows: OS421712-NS (lot 7891), OS421714-NS (lot 7891) OS421716-NS (lot 7891, 7520), OS421718-NS (lot 7891, 7520) OS421720-NS (lot 7891), OS421722-NS (lot 7891, 7520) OS421724-NS (lot 7891, 7520), OS421726-NS (lot 7891) OS421728-NS (lot 7891), OS421730-NS (lot 7891) OS421735-NS (lot 7520, 7891) ,OS421740-NS (lot 7520, 7891) OS421745-NS (lot 7520, 7891) ,OS421750-NS (lot 7520, 7891) OS421716 (lot 7519) ,OS421718 (lot 7519)
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US Distribution to states of: CA, CO, GA, IL, LA, NC, NY, TX and WA.
  • Product Description
    Ortho OS Solutions UltOS 3.5mm locking screw 12mm to 50mm Ortho Solutions LTD, Unit 5 West Station Business Park, Spital Road, Maldon, Essex CM96FF Rx Only a) Sterile b) Non-Sterile || Orthopaedic Bone Screw
  • Manufacturer
    Ortho Solutions Inc

Manufacturer

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