Class 2 Device Recall Matrix MAX 3

• Date Initiated by Firm: July 24, 2007
• Date Posted: November 16, 2007
• Recall Status: Terminated on April 26, 2013
• Recall Number: Z-0216-2008
• Recall Event ID: 44962
• Product: Matrix MAX3 Actuator, Catalog Number: MAX30 A300545A2510V000, SKF USA, Inc. Norristown, PA 19403
• Code Information: Serial number 3337328
• Recalling Firm/ Manufacturer: Skf USA Inc; 1111 Adams Ave; Norristown PA 19403-2403
• For Additional Information Contact: Michele Dyer; 610-630-2715
• Manufacturer Reason for Recall: Sudden failure of the actuator during lifting operation
• FDA Determined Cause: Labeling design
• Action: On or about 7/24/07, the firm sent an Important Safety Information letter and instructions to all known OEMs who purchase and sell SKF actuators for use in patient lifts. The letter reiterated and emphasized the importance of proper handling and maintenance for the actuator. The firm enclosed with this correspondence a proposed letter that the OEMs were asked to send to their customers, including the safety instructions and a new warning label. The firm also is making available for OEMs, dealers and their customers new warning labels to place on all actuators in service. The root cause of the problem is still under investigation by the recalling firm and additional instruction may follow later
• Quantity in Commerce: 1,298 units (Z-0215-0217-2008)
• Distribution: Worldwide Distribution-USA and Canada

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.