Events

Recall of ATTUNE CONV FB PS ARTICULATION SURFACE

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON 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
    113931
  • Event Risk Class
    II
  • Event Initiated Date
    2015-06-18
  • 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
    Depuy is issuing a device correction for all lots of attune tibial articulation surface instruments used in trialing with the attune knee system. the device correction is being issued due to the potential for the balseal which is a small wire spring coil located on the post feature of the articulation surface instruments to become damaged and disassociate (come off). the balseal is constructed from implant grade stainless steel. if the balseal is separated from the post it has the potential to enter the surgical site and be left in the patient if the surgeon is unaware of the disassociation.

Device

ATTUNE CONV FB PS ARTICULATION SURFACE
  • Model / Serial
    Model Catalog: 2545-01968 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: 2545-01967 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: 2545-01966 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: 2545-01964 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: 2545-01965 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: 2545-01963 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: 2545-00-962 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: 2545-00-961 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: 2545-01-000 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: 2545-00-999 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: 2545-00-992 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: 2545-00-991 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: 2545-00-980 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: 2545-00-979 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: 2545-00-972 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: 2545-00-9
  • Product Description
    ATTUNE CONV FB PS ARTICULATION SURFACE
  • Manufacturer
    JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON INC.

Manufacturer

JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON INC.