Events

Recall of CONGRUENT BONE PLATE SYSTEM - CORTICAL SCREW

According to Health Canada (via FOI), this recall involved a device in Canada 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
    128725
  • Event Risk Class
    III
  • Event Initiated Date
    2013-02-22
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    The product was potentially mixed during the packaging operation. the label may indicate the part is a col-3100 from batch 281069 but may actually be a col-3120 from batch 280748. or conversely the label may indicate a col-3120 screw and may actually be a col-3100.

Device

CONGRUENT BONE PLATE SYSTEM - CORTICAL SCREW
  • Model / Serial
    Model Catalog: COL-3100 (Lot serial: 280748); Model Catalog: COL-3120 (Lot serial: 281069); Model Catalog: COL-3100 (Lot serial: 281069); Model Catalog: COL-3120 (Lot serial: 280748)
  • Product Description
    locking cortical screws
  • Manufacturer
    ACUMED LLC

Manufacturer

ACUMED LLC
  • Manufacturer Address
    HILLSBORO
  • Manufacturer Parent Company (2017)
    Acumed Llc
  • Source
    HC