FDAFDA · Food and drugs·Recall number Z-1131-2014
Accessory shorts for the AlterG Anti-Gravity treadmill. Use with the AlterG Anti-Gravity Treadmill for rehabilitation.
Published March 12, 2014 · Recall initiated: January 28, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Unapproved material used by vendor in subset of shorts causing them to stretch more than usual and are uncomfortable for patient.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- AlterG, Incorporated
- Distributor
- Worldwide Distribution:US (nationwide) and to countries: Australia, Netherlands, United Kingdom, Spain, Germany, France, Denmark, Switzerland, Poland, Slovak Republic, Austria, and United Arab Emirates.
- Lot
- Product M320, Accessory Shorts with lot numbers XIN1212, XIN0413, XIN0213, XIN0313 and XIN0413,
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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