Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Accessory shorts for the AlterG Anti-Gravity treadmill. Use with the AlterG Anti-Gravity Treadmill for rehabilitation.

FDA Recall Z-1131-2014 · Posted 2014-03-04

Recalling FirmAlterG, Incorporated
Recall StatusTerminated
Product CodeIOL
Date Initiated2014-01-28
Date Terminated2014-05-13
Product Quantity2221 devices

Reason for Recall

Unapproved material used by vendor in subset of shorts causing them to stretch more than usual and are uncomfortable for patient.

Firm 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.

Root Cause

Component change control

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑