Events

Recall of EMAX SAGITTAL SAW - MOTOR

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
    55119
  • Event Risk Class
    II
  • Event Initiated Date
    2014-05-30
  • 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) was advised that anspach identified through internal sterility assurance level (sal)validation testing that several attachments failed to meet 10-6 sal when sterilized by the sterrad 100s sterilization method that is specified in the current directions for use (dfu) and operating manuals provided with the device.

Device

EMAX SAGITTAL SAW - MOTOR
  • Model / Serial
    Model Catalog: MM-SAGITTAL (Lot serial: >10 LOT#CONTACT MANUFACTURER); Model Catalog: DRIVER (Lot serial: >10 LOT#CONTACT MANUFACTURER); Model Catalog: S-SAW (Lot serial: >10 LOT#CONTACT MANUFACTURER); Model Catalog: SHORT (Lot serial: >10 LOT#CONTACT MANUFACTURER); Model Catalog: MEDIUM (Lot serial: >10 LOT#CONTACT MANUFACTURER); Model Catalog: LONG (Lot serial: >10 LOT#CONTACT MANUFACTURER); Model Catalog: O-SAW (Lot serial: >10 LOT#CONTACT MANUFACTURER); Model Catalog: B-SILVER (Lot serial: >10 LOT#CONTACT MANUFACTURER); Model Catalog: ADG (Lot serial: >10 LOT#CONTACT MANUFACTURER); Model Catalog: BLACKMAX-N (Lot serial: >10 LOT#CONTACT MANUFACTURER); Model Catalog: BLACKMAX-O (Lot serial: >10 LOT#CONTACT MANUFACTURER); Model Catalog: CRANI-A-R (Lot serial: >10 LOT#CONTACT MANUFACTURER); Model Catalog: EMAX2-HC (Lot serial: >10 LOT#CONTACT MANUFACTURER); Model Catalog: CRANI-A (Lot serial: >10 LOT#CONTACT MANUFACTURER); Model Catalog: CRANI-L (Lot serial: >10 LOT#CONTACT MANUFACTURER); Model Catalog: CRAN
  • Product Description
    EMAX SAGITTAL SAW - MOTOR
  • Manufacturer
    SYNTHES (CANADA) LTD.

Manufacturer

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