Device product
Accessory shorts for the AlterG Anti-Gravity treadmill. Use with the AlterG Anti-Gravity Treadmill for rehabilitation.
Z-1131-2014
Product summary
- Event
- Event 67435
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2221 devices
- Official record key
device-enforcement:Z-1131-2014
Official wording
Reason: Unapproved material used by vendor in subset of shorts causing them to stretch more than usual and are uncomfortable for patient.
Code information: Product M320, Accessory Shorts with lot numbers XIN1212, XIN0413, XIN0213, XIN0313 and XIN0413,
Distribution pattern: Worldwide Distribution:US (nationwide) and to countries: Australia, Netherlands, United Kingdom, Spain, Germany, France, Denmark, Switzerland, Poland, Slovak Republic, Austria, and United Arab Emirates.
Derived failure modes
-
Unknown
Unapproved material used by vendor in subset of shorts causing them to stretch more than usual and are uncomfortable for patient.