Events

Recall of NOBEL PARALLEL CC GUIDED SURGERY KIT

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by NOBEL BIOCARE CANADA 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
    109191
  • Event Risk Class
    III
  • Event Initiated Date
    2016-07-20
  • 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
    Nobel quality management systems have detected that the instructions for use (ifu) and the manual for guided surgery with nobelparallel conical connection implants include an incorrect drill protocol for the fully guided surgery using the 4.3 mm implant diameter in soft bone. the ifu and manual are related to the nobelparallel cc guided surgery kit article #38072. the instructions printed on the kit plate itself placed at the top of the plate reference the correct drills for all implant diameters and bone types.

Device

NOBEL PARALLEL CC GUIDED SURGERY KIT
  • Model / Serial
    Model Catalog: 38072 (Lot serial: all batches)
  • Product Description
    NOBEL PARALLEL CC GUIDED SURGERY KIT
  • Manufacturer
    NOBEL BIOCARE CANADA INC

Manufacturer

NOBEL BIOCARE CANADA INC