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U.S. Department of Health and Human Services

Class 2 Device Recall Matrix MAX 3

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  Class 2 Device Recall Matrix MAX 3 see related information
Date Initiated by Firm July 24, 2007
Date Posted November 16, 2007
Recall Status1 Terminated 3 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 2
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.
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