Recall Z-1131-2014 ยท IOL Treadmill, Powered
AlterG, Incorporated
Accessory shorts for the AlterG Anti-Gravity treadmill. Use with the AlterG Anti-Gravity Treadmill for rehabilitation.
| Date | Mar 4, 2014 (initiated Jan 28, 2014) |
| Status | Terminated |
| Reason | Unapproved material used by vendor in subset of shorts causing them to stretch more than usual and are uncomfortable for patient. |
| 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 |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.