Events

Recall of RECLAIM POLY TAPER PROTECTOR

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
    130988
  • Event Risk Class
    II
  • Event Initiated Date
    2014-07-02
  • 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 voluntary device correction is being initiated because the product the reclaim taper sleeve protector instrument (sold separately or assembled to the reclaim stem) can be difficult to remove from the distal stem both before surgery and after proximal reaming. the immediate remedy is for all users to discard the affected taper sleeve protector prior to stem implantation.

Device

RECLAIM POLY TAPER PROTECTOR
  • Model / Serial
    Model Catalog: 297500110 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: 1977-25-290 (Lot serial: >1000 NUMBERS CONTACT MFR); Model Catalog: 1977-26-190 (Lot serial: >1000 NUMBERS CONTACT MFR); Model Catalog: 1977-25-190 (Lot serial: >1000 NUMBERS CONTACT MFR); Model Catalog: 1977-24-240 (Lot serial: >1000 NUMBERS CONTACT MFR); Model Catalog: 1977-24-190 (Lot serial: >1000 NUMBERS CONTACT MFR); Model Catalog: 1977-23-290 (Lot serial: >1000 NUMBERS CONTACT MFR); Model Catalog: 1977-23-240 (Lot serial: >1000 NUMBERS CONTACT MFR); Model Catalog: 1977-23-190 (Lot serial: >1000 NUMBERS CONTACT MFR); Model Catalog: 1977-22-240 (Lot serial: >1000 NUMBERS CONTACT MFR); Model Catalog: 1977-22-190 (Lot serial: >1000 NUMBERS CONTACT MFR); Model Catalog: 1977-21-290 (Lot serial: >1000 NUMBERS CONTACT MFR); Model Catalog: 1977-21-240 (Lot serial: >1000 NUMBERS CONTACT MFR); Model Catalog: 1977-21-190 (Lot serial: >1000 NUMBERS CONTACT MFR); Model Catalog: 1977-20-290 (Lot serial: >1000 NUMBERS CONTACT MFR); Model C
  • Product Description
    RECLAIM TAPER SLEEVE PROTECTOR
  • Manufacturer
    JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON INC.

Manufacturer

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