Events

Recall of Device Recall The Polarus Plus Humeral Rod

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Acumed LLC.

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
    61333
  • Event Risk Class
    Class 2
  • Event Number
    Z-1357-2012
  • Event Initiated Date
    2012-03-07
  • Event Date Posted
    2012-04-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-07-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107816
  • 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
    Rod, fixation, intramedullary and accessories - Product Code HSB
  • Reason
    The packaging contains the wrong product. it does not contain model hr-0824-s as the package indicates.
  • Action
    Acumed sent an Urgent Notice Device Recall letter dated March 5, 2012, to all affected consignees. A follow-up notification letter was sent to the domestic customers on March 9, 2012. The letter identified the product, the problem, and the action to be taken by the consignee. The consignees were instructed to further notify their consignees about the recall and to cease use of and return the affected product. Consignees were requested to respond using the enclosed response form. The form should be faxed to 503-520-9618. For questions regarding this recall call 503-627-9957, ext. 1302.

Device

Device Recall The Polarus Plus Humeral Rod
  • Model / Serial
    LOT 266220
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of Italy, Ireland, and Great Britain.
  • Product Description
    The Polarus Plus Humeral Rod (part number HR-0824-S) is intended as an intramedullary fixation device for humeral fractures. It is sealed in an internal sterile blister pack within a box that is labeled in part: "Polarus Humeral Fixation System Size: 8mm X 240mm Polarus Plus Humeral Rod***Titanium***REF HR-0824-S***LOT 266220***RX only***Manufactured or distributed by: ACUMED 5885 NW Cornelius Pass Road Hillsboro, OR 97124 USA***"
  • Manufacturer
    Acumed LLC

Manufacturer

Acumed LLC
  • Manufacturer Address
    Acumed LLC, 5885 NW Cornelius Pass Rd, Hillsboro OR 97124-9432
  • Manufacturer Parent Company (2017)
    Acumed Llc
  • Source
    USFDA