Affixus Nail Recall

An investigation into the nail targeting jig assembly showed that certain specifications were undersized causing.

Affixus nail recall. The affixus hip fracture nail system provides an efficient practical solution for treating a wide range of proximal femoral fractures. First of all this is a retrospective uncontrolled study originating from 2 different. Terminated 3 on june 02 2020. Affixus hip fracture nail zimmer biomet is conducting a voluntary medical device field action for the affixus hip fracture nail due to issues with the nail not properly engaging with the targeting jig.

Systemic complications occurred in 29 patients 29 and local complications in 3 patients 3 including lag screw cutout in one patient 1. The mean acute hospital stay was 17 6 days. The mean follow up duration was 8 months range 3 32. Recall of affixus intramedullary hip fracture nail according to u s.

The average age was 85 years. Of the patients 83 were female. The fracture was treated by closed reduction and intramedullary fixation. The system combines the principles of a compression hip screw with the biomechanical advantage of an intramedullary nail.

A correction or removal action taken by a manufacturer to address a problem with a medical device. Terminated 3 on june 02 2020. Food and drug administration this recall involved a device in united states that was produced by zimmer biomet inc. Recalls occur when a medical device is defective when it could be a risk to health or when it.

The findings of this study should be considered with caution taking into account certain limitations. Urgent medical device recall removal lot specific affected product. A retrospective study of 100 unstable geriatric hip fractures treated with affixus hip fracture nail is presented. By combining a proximal 1 8m radius of curvature with a 3 degree distal bend the resultant bow is comparable to a proximal 1 5m radius.