Triathlon Distal Capture Assembly 의 리콜

Recall

RC-2015-RN-00140-1

Class II

2015-02-24

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00140-1

Stryker orthopaedics has received complaints regarding the disassociation of the cross pin from the action triggers of the triathlon distal capture assembly, which could lead to a loose or disassociated action trigger mechanism and/or loose or disassociated cross pin. although using a capture for the distal femoral resection or proximal tibial resection in a triathlon primary total knee arthroplasty is optional, if the surgeon elects to utilize a capture and such disassociation occurs, there exists the potential for the following harms:·complications associated with a delay in surgery of =15 minutes;·revision surgery to retrieve loose component(s);·local inflammatory response;·inflammatory response stryker representatives will contact customers to physically inspect and remove affected units in the field.

A Stryker representative will arrange for all non-conforming components to be removed and a replacement arranged as required. In the event a Stryker Representative is not available to visit your location to perform the inspection, detailed inspection instructions are provided via the Customer Letter. This action has been closed-out on 21/04/2017.