Events

Recall of BONE LEVEL IMPLANT RC SLACTIVE ROXOLID LOXIM

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
    44408
  • Event Risk Class
    II
  • Event Initiated Date
    2014-09-29
  • 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
    It was determined that lot gy256 incorporates the nc version of the loxim transfer piece rather than the proper rc version. this error could result in the inability to drive the implant into the prepared osteotomy. the transfer piece would turn within the implant and the implant would not advance into the bone.

Device

BONE LEVEL IMPLANT RC SLACTIVE ROXOLID LOXIM
  • Model / Serial
    Model Catalog: 021.4308 (Lot serial: GY256)
  • Product Description
    BONE LEVEL 4.1MM RC SLACTIVE 8MM TIZR LOXIM IMPLANT
  • Manufacturer
    STRAUMANN CANADA LIMITED

Manufacturer

STRAUMANN CANADA LIMITED