Events

Recall of Device Recall Ossur Lil Angel Vest

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Ossur H / F.

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
    73382
  • Event Risk Class
    Class 2
  • Event Number
    Z-1510-2016
  • Event Initiated Date
    2016-03-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-08-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144630
  • 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
    Component, traction, non-invasive - Product Code KQZ
  • Reason
    There is a potential for partial or complete fracture of the plastic stabilizer strap on the vest.
  • Action
    Customer notification letter were sent on 03/14/16 via traceable method. The notification asked customers to examine their inventory, quarantine product subject to the recall and contact customer service for a return authorization to return the product to Ossur. Customers were asked to take the following actions: 1. Pass the notice to those who need to be aware within the organization or to any organization where the potentially affected devices have been transferred. 2. Maintain awareness on the notice for an appropriate period. 3. If have further distributed this product identify the customers and notify them at once of this product alert. It is recommended that a copy of the notice is included. 4. If any customers are currently wearing a product it is recommended a detailed inspection of the product vest structurebe conducted to ensure there is no visible cracks on the vest.

Device

Device Recall Ossur Lil Angel Vest
  • Model / Serial
    P/N: 545100K units from 2008 to current
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Distribution US Nationwide and Hong Kong
  • Product Description
    Ossur Lil Angel Vest P2 Kodel. Pediatric sized vest is a support structure used with the halo system for traumatic or chronic disorders requiring traction along the cervical spine.
  • Manufacturer
    Ossur H / F

Manufacturer

Ossur H / F
  • Manufacturer Address
    Ossur H / F, Grjothals 5, Reykjavik Iceland
  • Manufacturer Parent Company (2017)
    Össur hf
  • Source
    USFDA