Duracon Augments - Tibial Wedge Implants 의 리콜

Recall

RC-2015-RN-00971-1

Class II

2015-10-02

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00971-1

Stryker has received two customer complaints regarding duracon tibial wedge implants that had punctured the packaging’s tyvek lid. in each case, the punctured tyvek lid was identified in the operating room and a new device was opened and used.In all stryker instructions for use (ifu) for the above referenced product, the end user is instructed to inspect the package for damage and, if present, to discard the device. operating room staff should conduct this packaging inspection for any breach in the outer and inner packaging. performing this inspection should mitigate this potential hazard. in the unlikely event the packaging is not inspected, there is a potential that a non-sterile implant will be implanted which may result in a post-operative infection.

All affected products in the market have been recorded as being used. Stryker has decided that the implanting and treating physicians should be made aware of this issue to facilitate review of their patients for this issue as part of the normal post-operative course of treatment. Stryker recognises that the implanting and treating physicians are in the best position to exercise the necessary medical judgment for their patients . This action has been closed-out on 05/12/2016.