Pull Reduction Device for Percustaneous Drill Guide 4.3mm (Supplied as part of the VA Distal Femur set) 의 리콜

Recall

RC-2015-RN-00569-1

Class II

2015-06-29

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00569-1

The affected parts and lots of the pull reduction devices may have been manufactured to an incorrect hardness specification whichcould result in intraoperative breakage.In the event of an intraoperative breakage a surgical delay could occur. breakage of the instrument into fragments during active use could lead to a significant prolongation of surgery time as the surgeon attempts to retrieve the pieces including use radiographic imaging to determine location and size of fragment.

Johnson & Johnson Medical is requesting their customers to check their inventory to determine if they have any affected product. Affected stock must be quarantined in preparation for return to Johnson & Johnson Medical. This action has been closed-out on 05/12/2016.