Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1131-2014Class II

Accessory shorts for the AlterG Anti-Gravity treadmill. Use with the AlterG Anti-Gravity Treadmill for...

AlterG, Incorporated / initiated 2014-01-28 / Terminated / root cause: supplier

AlterG, Incorporated began a recall of Accessory shorts for the AlterG Anti-Gravity treadmill. Use with the AlterG Anti-Gravity Treadmill for rehabilitation on . FDA classified it as Class II and gives the reason as "Unapproved material used by vendor in subset of shorts causing them to stretch more than usual and are uncomfortable for patient". As of , the recall status on record is Terminated, and MDM tags the root cause as supplier.

Recall record

Recall number
Z-1131-2014
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
AlterG, Incorporated
Product
Accessory shorts for the AlterG Anti-Gravity treadmill. Use with the AlterG Anti-Gravity Treadmill for rehabilitation.
Product code
IOL Treadmill, Powered
Reason for recall
Unapproved material used by vendor in subset of shorts causing them to stretch more than usual and are uncomfortable for patient.
Root cause tag
supplier
FDA root cause
Component change control
Action
The firm, AlterG, Inc, sent "Medical Device Recall Notification Anti-Gravity Short Exchange" letters dated February 6, 2014 to all customers beginning February 7, 2014 by Federal Express. The letter describes the product, problem and actions to be taken. The customers were instructed to review your inventory of shorts to identify any that are labeled ZIN1212 or ZIN0413 and return any shorts with these labeled production date using the return label provided. If you have any questions about this shorts exchange program or if there are any other ways we can be of assistance to you, please email us at [email protected] or call the support team at any time at 510-2705369.
Quantity in commerce
2221 devices
Distribution
Worldwide Distribution:US (nationwide) and to countries: Australia, Netherlands, United Kingdom, Spain, Germany, France, Denmark, Switzerland, Poland, Slovak Republic, Austria, and United Arab Emirates.
Product codes and lots
Product M320, Accessory Shorts with lot numbers XIN1212, XIN0413, XIN0213, XIN0313 and XIN0413,

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-1131-2014
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-1131-2014Class IITerminatedVoluntary: Firm initiated