Orthopaedic bone plates and cortical screws 를 위한 안전성 경고 / 현장 안전성 서한

Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and the United Kingdom.

In May 2018, Newdeal SAS, a company within Integra LifeSciences Group, issued a Field Safety Notice informing distributors and clinicians of devices possibly affected with defective packaging. This defect may result in insufficient sealing, a potential consequence of which is an increased risk of infection.This Medical Device Alert is being issued to ensure that all hospitals are aware of the issue and that adequate action is taken to mitigate potential risk to patients.