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Ossur H / F recalls LP Rotate Foot System prosthetic device for fitting lower extremity amputations. -Low profile foot module with adjust
Recalled March 25, 2015 · FDA recall Z-1288-2015 · Ossur H / F
Hazard
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. · FDA Class II
Units
2,194 (1,464 in U.S. and 730 internationally)
Sold at
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,
Description
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.
Product
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
Manufacturer(s)
Ossur H / F
Made in
Iceland
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →