Z-1131-2014 Class II Terminated
FDA device recall Z-1131-2014 was initiated by AlterG, Incorporated on January 28, 2014 and is designated Class II. Reason for recall: Unapproved material used by vendor in subset of shorts causing them to stretch more than usual and are uncomfortable for patient. The recall status is terminated (terminated May 13, 2014). Affected quantity: 2221 devices.
Recall Details
- Product Type
- Devices
- Report Date
- March 12, 2014
- Initiation Date
- January 28, 2014
- Termination Date
- May 13, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2221 devices
Product Description
Accessory shorts for the AlterG Anti-Gravity treadmill. Use with the AlterG Anti-Gravity Treadmill for rehabilitation.
Reason for Recall
Unapproved material used by vendor in subset of shorts causing them to stretch more than usual and are uncomfortable for patient.
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.
Code Information
Product M320, Accessory Shorts with lot numbers XIN1212, XIN0413, XIN0213, XIN0313 and XIN0413,