Affixus Nail Recall
Https Www Igj Nl Binaries Igj Documenten Waarschuwingen 2018 08 22 Zimmer Biomet Zfa2018 00413 Zimmer Biomet Is Conducting A Lot Specific Medical Device Field Action Removal For The Affixus Hip Fracture Nail Due To Complaints Indicating That When The Product Was Opened In Surgery The Sterile Packaging Was Already Open It2015290 Zimmer Biomet Zfa 2018 00413 Affixus C2 Ae Hip Fracture Nail Pdf
An investigation into the nail targeting jig assembly showed that certain specifications were undersized causing.
Affixus nail recall. 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. Of the patients 83 were female. The present study aims to provide preliminary evidence of the use of a nail affixus of the latest generation designed recently for proximal femoral fractures especially of the elderly population.
The mean acute hospital stay was 17 6 days. A correction or removal action taken by a manufacturer to address a problem with a medical device. A retrospective study of 100 unstable geriatric hip fractures treated with affixus hip fracture nail is presented. Terminated 3 on june 02 2020.
Recalls occur when a medical device is defective when it could be a risk to health or when it. The affixus hip fracture nail system provides an efficient practical solution for treating a wide range of proximal femoral fractures. Rod fixation intramedullary and accessories. First of all this is a retrospective uncontrolled study originating from 2 different.
Food and drug administration this recall involved a device in united states that was produced by zimmer biomet inc. Terminated 3 on june 02 2020. The findings of this study should be considered with caution taking into account certain limitations. Rod fixation intramedullary and accessories.
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. Urgent medical device recall removal lot specific affected product. The mean follow up duration was 8 months range 3 32. Systemic complications occurred in 29 patients 29 and local complications in 3 patients 3 including lag screw cutout in one patient 1.