Events

Recall of SYNTHES VERTICAL EXPANDABLE PROSTHETIC TITANIUM RIB SYSTEM-INFERIOR CRADLE

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
    43409
  • Event Risk Class
    II
  • Event Initiated Date
    2015-08-05
  • 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
    This recall is being initiated because the last hole on the veptr caudal rib supports subject to this recall may be partially formed. fully lengthening the construct to the partially formed last hole may result in mechanical failure of the construct due to extension bar breakage which could require unplanned surgical intervention to exchange components. in addition to the risks inherent to re-operation potential effects on the patient could also include pain loss of deformity correction and/or soft tissue/visceral injury.

Device

SYNTHES VERTICAL EXPANDABLE PROSTHETIC TITANIUM RIB SYSTEM-INFERIOR CRADLE
  • Model / Serial
    Model Catalog: 497.231 (Lot serial: >100 NUMBERS CONTACT MFG); Model Catalog: 497.230 (Lot serial: >100 NUMBERS CONTACT MFG); Model Catalog: 497.229 (Lot serial: >100 NUMBERS CONTACT MFG); Model Catalog: 497.228 (Lot serial: >100 NUMBERS CONTACT MFG); Model Catalog: 497.227 (Lot serial: >100 NUMBERS CONTACT MFG); Model Catalog: 497.226 (Lot serial: >100 NUMBERS CONTACT MFG); Model Catalog: 497.225 (Lot serial: >100 NUMBERS CONTACT MFG); Model Catalog: 497.249 (Lot serial: >100 NUMBERS CONTACT MFG); Model Catalog: 497.248 (Lot serial: >100 NUMBERS CONTACT MFG); Model Catalog: 497.247 (Lot serial: >100 NUMBERS CONTACT MFG); Model Catalog: 497.100 (Lot serial: >100 NUMBERS CONTACT MFG); Model Catalog: 497.099 (Lot serial: >100 NUMBERS CONTACT MFG); Model Catalog: 497.098 (Lot serial: >100 NUMBERS CONTACT MFG); Model Catalog: 497.246 (Lot serial: >100 NUMBERS CONTACT MFG); Model Catalog: 497.245 (Lot serial: >100 NUMBERS CONTACT MFG); Model Catalog: 497.244 (Lot serial: >100 NUMBERS CONTACT MFG); Model Catalog:
  • Product Description
    (VEPTR) VERTICAL EXPANDABLE PROSTHETIC TITANIUM RIB CAUDAL RIB SUPPORTS
  • Manufacturer
    JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON INC.

Manufacturer

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