Ossur H / F recalls LP Rotate Foot System prosthetic device for fitting lower extremity amputations. -Low profile foot module with adjustab…

Recall date

March 4, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1288-2015

FDA classification

Class II

Brand / firm

Ossur H / F

Sold / distributed

Nationwide within the U.S. and internationally to the following foreign countries; Belgium, United Kingdom, Germany, Czech Republic, France, Israel, Poland, Spain, Australia, Japan, Mexico, Bulgaria, Canada, South Korea, Sweden, Finland,

Why it was recalled

The threads of the outer tube of the shock module of LP Rotate are too short, resulting in insecure assembly. Use of the product may cause the patient to fall with continued use, as the shock module can become loose from the foot blade.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

LP Rotate Foot System prosthetic device for fitting lower extremity amputations. -Low profile foot module with adjustable shock absorber and rotation with progressive stiffening -Build height: with male pyramid adapter 145 - 153mm (5 11/16 - 6 ) with female pyramid adapter 153 165mm (6 - 6 1/2) -Male pyramid adapter -Female pyramid adapter -Maintenance free, no lubrication required -Maximum weight: 147kg (325lbs) -Available in sizes 22-30