Events

Recall of DELTA XTEND REVERSE SHOULDER SYSTEM - MODULAR ECCENTRIC EPIPHYSIS

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
    72979
  • Event Risk Class
    II
  • Event Initiated Date
    2017-09-15
  • 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 synthes is initiating a voluntary recall. for the recalled lots an investigation determined that lots produced in a specific machine were manufactured in a manner in which the post's diameter is out-of-specification. further investigation determined that the issue is related to the circularity of the cylinder. the circularity issue may cause the epiphysis to interfere with the stem and the two implants (epiphysis and stem) may not be able to be assembled.

Device

DELTA XTEND REVERSE SHOULDER SYSTEM - MODULAR ECCENTRIC EPIPHYSIS
  • Model / Serial
    Model Catalog: 130720203 (Lot serial: >100 NUMBERS CONTACT MFG); Model Catalog: 130720201 (Lot serial: >100 NUMBERS CONTACT MFG); Model Catalog: 130720101 (Lot serial: >100 NUMBERS CONTACT MFG); Model Catalog: 130720102 (Lot serial: >100 NUMBERS CONTACT MFG); Model Catalog: 130720202 (Lot serial: >100 NUMBERS CONTACT MFG); Model Catalog: 130720103 (Lot serial: >100 NUMBERS CONTACT MFG)
  • Product Description
    DELTA XTEND REVERSE SHOULDER SYSTEM - MODULAR ECCENTRIC EPIPHYSIS;DELTA XTEND REVERSE SHOULDER SYSTEM -MODULAR CEMENTED EPIPHYSIS
  • Manufacturer
    JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON INC.

Manufacturer

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