Events

Recall of RIA SYSTEM - REAMER HEAD STERILE

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

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
    55733
  • Event Risk Class
    II
  • Event Initiated Date
    2015-06-15
  • 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
    Synthes canada ltd. is initiating a voluntary medical device labelling recall for synthes reamer/irrigator /aspirator (ria) system technique guide (j4352). precautionary statements are being added to the "reamer /irrigator/ aspirator (ria) surgical technique guide". it was reported that the ria drive shaft tube assembly and reamer head have the potential to break when incorrectly assembled or used improperly as follows: 1. failure to fully engage the reamer to shaft at assembly prior to surgery. incorrect assembly creates a reduced reamer/shaft contact surface area in which excess rotational forces could cause breakage 2. use of ria drive shafts after the flats have become worn and rounded 3. use of any excess force beyond design limit 4. use of with an incompatible power tool.

Device

RIA SYSTEM - REAMER HEAD STERILE
  • Model / Serial
    Model Catalog: 352.263S (Lot serial: All revisions); Model Catalog: 352.262S (Lot serial: All revisions); Model Catalog: 352.261S (Lot serial: All revisions); Model Catalog: 352.259S (Lot serial: All revisions); Model Catalog: 352.250S (Lot serial: All revisions); Model Catalog: 352.257S (Lot serial: All revisions); Model Catalog: 352.256S (Lot serial: All revisions); Model Catalog: 352.255S (Lot serial: All revisions); Model Catalog: 352.254S (Lot serial: All revisions); Model Catalog: 352.253S (Lot serial: All revisions); Model Catalog: 352.252S (Lot serial: All revisions); Model Catalog: 352.251S (Lot serial: All revisions); Model Catalog: 352.264S (Lot serial: All revisions); Model Catalog: 352.265S (Lot serial: All revisions); Model Catalog: 352.258S (Lot serial: All revisions); Model Catalog: 314.743 (Lot serial: All revisions); Model Catalog: 314.742 (Lot serial: All revisions); Model Catalog: 314.745S (Lot serial: All revisions); Model Catalog: 314.746S (Lot serial: All revisions)
  • Product Description
    RIA SYSTEM - REAMER HEAD STERILE
  • Manufacturer
    SYNTHES (CANADA) LTD.

Manufacturer

SYNTHES (CANADA) LTD.
  • Manufacturer Address
    MISSISSAUGA
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Source
    HC