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| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1131-2014 | Class II | Terminated | Voluntary: Firm initiated |
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