Events

Recall of GENESIS II FINNED STEM TIBIAL PUNCH

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by SMITH & NEPHEW 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
    16626
  • Event Risk Class
    II
  • Event Initiated Date
    2006-09-01
  • 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
    Punches were not manufactured to our specifications and the tip of the punch is welded on and not one piece as specified. this can cause the tip of the punch to break off during use.

Device

GENESIS II FINNED STEM TIBIAL PUNCH
  • Model / Serial
    Model Catalog: P/N 71434306 (Lot serial: EX. 00511384).); Model Catalog: P/N 71434304 (Lot serial: EX. 00511384).); Model Catalog: P/N 71434301 (Lot serial: ALL LOTS PRIOR TO); Model Catalog: P/N 71434302 (Lot serial: ALL LOTS PRIOR TO); Model Catalog: P/N 71434304 (Lot serial: ALL LOTS PRIOR TO); Model Catalog: P/N 71434306 (Lot serial: ALL LOTS PRIOR TO); Model Catalog: P/N 71434301 (Lot serial: 06MM***** SEQUENCE INCLUDING); Model Catalog: P/N 71434302 (Lot serial: 06MM***** SEQUENCE INCLUDING); Model Catalog: P/N 71434304 (Lot serial: 06MM***** SEQUENCE INCLUDING); Model Catalog: P/N 71434306 (Lot serial: 06MM***** SEQUENCE INCLUDING); Model Catalog: P/N 71434301 (Lot serial: THOSE ITEMS WITH SUFFIXES); Model Catalog: P/N 71434302 (Lot serial: THOSE ITEMS WITH SUFFIXES); Model Catalog: P/N 71434304 (Lot serial: THOSE ITEMS WITH SUFFIXES); Model Catalog: P/N 71434306 (Lot serial: THOSE ITEMS WITH SUFFIXES); Model Catalog: P/N 71434301 (Lot serial: (EX. 05LM03346B AND WITHOUT); Model Catalog: P/N 71434302
  • Product Description
    GENESIS II nonporous tibial punch
  • Manufacturer
    SMITH & NEPHEW INC.

Manufacturer

SMITH & NEPHEW INC.