Events

Recall of Device Recall 3.5mm X 32.5mm Cortical Screw

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
    48468
  • Event Risk Class
    Class 2
  • Event Number
    Z-2155-2008
  • Event Initiated Date
    2005-12-27
  • Event Date Posted
    2008-08-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-02-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=71482
  • 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
    Bone fixation screw - Product Code HWC
  • Reason
    Package of 3.5mm x 32.5mm cortical screw may contain 3.5mm x 22.5mm cortical screw.
  • Action
    The firm issued a Product Removal notification on 12-27-2005 to their customers. The notification was sent by either FAX or by e-mail. The Product Removal Notification informed their customers of the issue, asked them to remove the screws from inventory and return the screws to Acumed. A reminder notification, dated 1/20/08 was issued to customers identifying the product and the problem and requesting the product be returned.

Device

Device Recall 3.5mm X 32.5mm Cortical Screw
  • Model / Serial
    Lot: W24552; Expiration date: 2010-05
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution --- USA including states of CA, KY, FL, TX, OH, OR, NY, ID NJ, NE, LA, WI, UT, MO, MS, GA, AZ and countries of United Kingdom, Italy, Puerto Rico, Turkey, Spain, Japan, South Africa, and Belgium.
  • Product Description
    3.5mm X 32.5mm Cortical Screw used with the Polarus Humeral Fixation System,. Product labeled in part, "Polarus Humeral Fixation System& SIZE: 3.5mm X 32.5mm Cortical Screw... REF HCO3325-S... Acumed 5885 NW Cornelius Pass Road Hillsboro, OR 97124-9432 ". || Polarus Humeral Fixation System, 3.5mm X 32.5mm Cortical Screw are packaged in a sterile inner package which are placed into an outer box. The cortical screws are used with the Polarus Locking Humeral Rod (Polarus Huemral Fixation System) for the multi-planar fixation. The screws are sold individually to support the Polarus Locking Humeral Rod systems in the field.
  • Manufacturer
    Acumed LLC

Manufacturer

Acumed LLC
  • Manufacturer Address
    Acumed LLC, 5885 NW Cornelius Pass Rd, Hillsboro OR 97124-9370
  • Manufacturer Parent Company (2017)
    Acumed Llc
  • Source
    USFDA