Events

Recall of SIGMA PLI INSERT

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
    40290
  • Event Risk Class
    III
  • Event Initiated Date
    2013-06-18
  • 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
    The compatibility chart on the product label and operating room reference chart literature/poster erroneously states that the size 6 posterior stabilized (ps) femoral component is compatible with the size 4 posterior stabilized (ps) tibial inserts and size 4 stabilized plus (sp) tibial inserts. the size 6 ps femoral component is not approved for use with either of these size 4 inserts and should not be implanted with either of these size 4 inserts. this correction affects the listed sigma knee system tibial inserts only.

Device

SIGMA PLI INSERT
  • Model / Serial
    Model Catalog: 1581-05-108 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: 1581-04-120 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: 1581-04-117 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: 1581-04-115 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: 1581-04-112 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: 1581-04-110 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: 1581-04-108 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: 1581-03-120 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: 1581-03-117 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: 1581-03-115 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: 1581-03-112 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: 1581-03-110 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: 1581-03-108 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: 1581-02-120 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: 1581-02-117 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: 158
  • Product Description
    SIGMA PLI TIBIAL INSERT
  • Manufacturer
    JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON INC.

Manufacturer

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