Events

Recall of T2 ARTHRODESIS NAIL LEFT STERILE

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by STRYKER TRAUMA GMBH.

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
    49557
  • Event Risk Class
    II
  • Event Initiated Date
    2012-01-17
  • 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
    Strykerr trauma has become aware of the potential for the sterility of above noted t2 knee nails to become compromised following high volume transport. in all cases the protection cap came off the nail and the nail had punctured the pouches which led to loss of sterility of the nail.

Device

T2 ARTHRODESIS NAIL LEFT STERILE
  • Model / Serial
    Model Catalog: CONTACT MANUFACTURER (Lot serial: CONTACT MANUFACTURER); Model Catalog: 1829-1124S (Lot serial: CONTACT MANUFACTURER); Model Catalog: 1829-1104S (Lot serial: CONTACT MANUFACTURER); Model Catalog: 1829-1112S (Lot serial: CONTACT MANUFACTURER); Model Catalog: 1829-1108S (Lot serial: CONTACT MANUFACTURER); Model Catalog: 1829-1116S (Lot serial: CONTACT MANUFACTURER); Model Catalog: CONTACT MANUFACTURER (Lot serial: ); Model Catalog: 1829-1170S (Lot serial: ); Model Catalog: 1829-1154S (Lot serial: ); Model Catalog: 1829-1162S (Lot serial: ); Model Catalog: 1829-1158S (Lot serial: ); Model Catalog: 1829-1166S (Lot serial: )
  • Product Description
    t3 ARTHRODESIS NAIL LEFT STERILE
  • Manufacturer
    STRYKER TRAUMA GMBH

Manufacturer

STRYKER TRAUMA GMBH
  • Manufacturer Address
    SCHOENKIRCHEN
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    HC