Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0217-2008

Matrix MAX3 Actuator, Catalog Number: MAX30 A300515A254L000, SKF USA, Inc. Norristown, PA 19403

Skf USA Inc / initiated 2007-07-24 / Terminated / root cause: labeling and UDI

Skf USA Inc began a recall of Matrix MAX3 Actuator, Catalog Number: MAX30 A300515A254L000, SKF USA, Inc. Norristown, PA 19403 on . The reason FDA records is "Sudden failure of the actuator during lifting operation". As of , the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number
Z-0217-2008
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Skf USA Inc
Product
Matrix MAX3 Actuator, Catalog Number: MAX30 A300515A254L000, SKF USA, Inc. Norristown, PA 19403
Reason for recall
Sudden failure of the actuator during lifting operation
Root cause tag
labeling and UDI
FDA root 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
Product codes and lots
Serial number 3072047