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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device assembly, knee/shank/ankle/foot, external
Regulation Description External assembled lower limb prosthesis.
Product CodeISW
Regulation Number 890.3500
Device Class 2

Device Problems
Device Operates Differently Than Expected 9
Solder Joint Fracture 2
Adverse Event Without Identified Device or Use Problem 2
Manufacturing, Packaging or Shipping Problem 1
Electrical /Electronic Property Problem 1
Material Fragmentation 1
Device Misassembled During Manufacturing / Shipping 1
Material Protrusion / Extrusion 1
Human Factors Issue 1
Mechanical Problem 1
Inadequate Service 1
Battery Problem 1
Total Device Problems 22

Recalls
Manufacturer Recall Class Date Posted
1 Ability Dynamics LLC II Jun-18-2014
2 Ossur H / F II Mar-25-2015
3 Otto Bock Healthcare Product II Aug-21-2015

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