Goal
The project goal was to lead the global recall of Post-Operative Knee Brace medical device
Background
A US-based orthopedic rehabilitation products company designs and manufactures, a knee brace intended to control the range of motion at the knee joint following surgeries and other structural repairs. Due to a failure in the mechanical hinge, the locking mechanism may fail potentially causing an adverse event.
Objectives
- Assess the recall classification and reporting requirements to the FDA
- Lead recall activities of 1,557 braces
- Lead communication, Health Hazard Assessment, reporting, and status updates with the FDA
- Notify global governments of recall, coordinate status, and close out reports
- Coordinate witness of destruction by FDA and manufacturer
Regulatory Need
Global recall of company-labeled and co-branded knee braces
Activities
- Create 7 SOP and 10 WI specific to recall activities
- Initiate root cause analysis and corrective/preventive action with critical vendor
- Develop trace mechanisms to identify the status of affected braces
- Guidance with notification letters and follow-up process
- Develop quality system strategy to QSR and ISO 13485
- Lead contact with FDA throughout the entire process until successful recall close-out
Outcome
Secure FDA Recall Termination Letter (recall closed) in 3 months
About MAE Group
MAE Group is a business service provider specializing in
domestic and international Regulatory Affairs, Clinical Affairs, Quality Systems, Cybersecurity, and Networked Security services to healthcare companies to commercialize medical and in vitro diagnostic devices in target markets.
