Events

Recall of STRAUMANN ORTHO SYSTEM - PALATAL IMPLANT SYSTEM - PALATAL IMPLANT TI

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by STRAUMANN CANADA LIMITED.

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
    14671
  • Event Risk Class
    II
  • Event Initiated Date
    2008-07-28
  • 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
    Recent testing shows that the transfer piece which accompanies the palatal implant may get stuck on the implant during placement and may only be removed by applying mechanical forces.

Device

STRAUMANN ORTHO SYSTEM - PALATAL IMPLANT SYSTEM - PALATAL IMPLANT TI
  • Model / Serial
    Model Catalog: 042.336S (Lot serial: lot 1001 catalog # 042.336S); Model Catalog: 042.335S (Lot serial: lot 1001 catalog # 042.336S); Model Catalog: 042.336S (Lot serial: lot 1001 catalog # 042.335S); Model Catalog: 042.335S (Lot serial: lot 1001 catalog # 042.335S); Model Catalog: 042.336S (Lot serial: lot E3289 catalog # 042.335S); Model Catalog: 042.335S (Lot serial: lot E3289 catalog # 042.335S); Model Catalog: 042.336S (Lot serial: lot F3776 catalog # 042.335S); Model Catalog: 042.335S (Lot serial: lot F3776 catalog # 042.335S); Model Catalog: 042.335S (Lot serial: lot F0597 catalog # 042.335S); Model Catalog: 042.335S (Lot serial: lot E5455 catalog # 042.335S); Model Catalog: 042.336S (Lot serial: lot E5455 catalog # 042.335S); Model Catalog: 042.335S (Lot serial: lot F4662 catalog # 042.335S); Model Catalog: 042.336S (Lot serial: lot F4662 catalog # 042.335S); Model Catalog: 042.335S (Lot serial: lot C9930 catalog # 042.335S); Model Catalog: 042.336S (Lot serial: lot C9930 catalog # 042.335S); Model C
  • Product Description
    STRAUMANN PALATAL IMPLANT
  • Manufacturer
    STRAUMANN CANADA LIMITED

Manufacturer

STRAUMANN CANADA LIMITED