Print version of this report

Type of Product	Medical Device
TGA Recall Reference	RC-2014-RN-00717-1
Product Name/Description	RECLAIM Distal Stem with Taper Sleeve Protector (Press-fit hip femur prosthesis) Part Numbers: Multiple All Lots
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	8/07/2014
Responsible Entity	Johnson & Johnson Medical Pty Ltd T/A Depuy Australia
Reason/Issue	Johnson & Johnson Medical Pty. Ltd (JJM) is notifying surgeons of a change to the surgical procedure for all lots of RECLAIM Taper Sleeve Protector because the product can be difficult to remove from the distal stem both before surgery and after proximal reaming.
Recall Action	Recall for Product Correction
Recall Action Instructions	Johnson & Johnson Medical is advising surgeons to remove the Taper Sleeve Protector prior to implantation of the RECLAIM Distal Stem. JJM will remove the Taper Sleeve Protector from future Distal Stems.
Contact Information	02 9815 3776 - Johnson & Johnson Medical