Cranial Screw PlusDrive ø 1.6 mm, Self-Drilling, L 3mm (part of the Low Profile Neuro System intended for use in selective trauma of the midface and craniofacial skeleton) 의 리콜

Recall

RC-2016-RN-00256-1

Class II

2016-03-08

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00256-1

The affected part number and lot numbers are out of specification at the thread. this is related to a non-conformance where the thread height of these screws is under-sized. it was also identified that the cross section of the affected area is less than that of conforming screws such that the thread height of the screws is under-sized.The decreased thread height may alter the self-drilling feature and result in difficulty inserting the screw. if the surgeon finds that the screw is not inserting as anticipated, the surgeon may choose to use a different screw or drill a pilot hole to insert the screw. attempting to insert additional screws or possibly drill with another instrument could result in a surgical delay. should the user be able to insert the screw the decreased thread height may significantly reduce the retention ability of the screw in the bone. these issues may require medical or surgical intervention to secure components or stabilise the structure or bone.

Johnson & Johnson Medical (JJM) are advising users to remove and return all opened Titanium Low Profile Neuro Screw; Self- Drilling 3mm screws in stock, and to remove and return only affected lots of unopened screws in their original packaging. This action has been closed-out on 25/01/2017.