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Terminated

RUSH81 Prosthetic Foot Product Usage: Prosthetic foot for human use

FDA Recall Z-1825-2014 · Posted 2014-06-18

Recalling FirmAbility Dynamics LLC
Recall StatusTerminated
Product CodeISW
Date Initiated2014-06-02
Date Terminated2014-09-22
Product Quantity175 units

Reason for Recall

Ability Dynamics is recalling RUSH81 Prosthetic Foot because the existing bolts may be bottomed out in the threaded hole and this could lead to bolt failure.

Firm Action

Ability Dynamics sent an Urgent Medical Device Correction Notice letter dated June 2, 2014 to all affected customers (Prosthetist) who purchased the RUSH Prosthetic Foot. The letter informs the customers of the problems identified and the actions to be taken. Customers are instructed to fill out the Bracket Bolt Replacement Form and return to Ability Dynamics. Customers with questions are instructed to contact Rich Sainz, National Clinical Manager, 2082 E. University Dr. Tempe AZ 85281 (480) 717-1412, [email protected].

Root Cause

Device Design

Distribution Pattern

Worldwide Distribution - US (nationwide) and in the countries of Australia and Canada.

Official Source

View FDA Recall →

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

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