Class 2 Device Recall Savaria Stairfriend

• Date Initiated by Firm: April 12, 2017
• Create Date: April 27, 2017
• Recall Status: Terminated on October 16, 2017
• Recall Number: Z-1882-2017
• Recall Event ID: 77042
• Product Classification: Transport, patient, powered - Product Code ILK
• Product: The Savaria Stairfriend is a Residential, commercial, indoor, stair lift for curved stairs.
• Code Information: s/n or lot number - 690009 thru 690235
• Recalling Firm/ Manufacturer: Savaria Concord Lifts, Inc.; 2 Walker Dr; Brampton Canada
• Manufacturer Reason for Recall: Savaria Concord Lifts has decided to initiate a recall of the Stairfriend, because of product defect. The product defect relates to poor quality of welding holding the seat post .
• FDA Determined Cause: Nonconforming Material/Component
• Action: The firm plans to notify its customers thru the phone and also via the dealers it sells it product too.
• Quantity in Commerce: 226
• Distribution: North America / South America, please see attached list.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.