Recall Z-1825-2014— Ability Dynamics LLC

Name: FDA recall Z-1825-2014
Creator: U.S. Food and Drug Administration
Published: 2014-06-02

Class II · Terminated

Class II FDA medical device recall by Ability Dynamics LLC, initiated 2014-06-02, terminated 2014-09-22. FDA's recall record names no specific 510(k) clearance for this event. Product: RUSH81 Prosthetic Foot Product Usage: Prosthetic foot for human use. Reason: 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..

Recalling firm: Ability Dynamics LLC
Classification: Class II
Status: Terminated
Initiated: 2014-06-02
Terminated: 2014-09-22
Firm location: Tempe, AZ, United States

Product description

RUSH81 Prosthetic Foot Product Usage: Prosthetic foot for human use

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.