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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search Show TPLC since Back To Search Results
Device joint, knee, external brace
Regulation Description Limb orthosis.
Product CodeITQ
Regulation Number 890.3475
Device Class 1

Device Problems
Adverse Event Without Identified Device or Use Problem 79
Patient Device Interaction Problem 8
Break 5
Patient-Device Incompatibility 3
Collapse 2
Material Twisted / Bent 2
Inadequacy of Device Shape and/or Size 2
Device Operates Differently Than Expected 2
Insufficient Information 1
Mechanical Problem 1
Deformation Due to Compressive Stress 1
Detachment Of Device Component 1
Component Incompatible 1
Material Deformation 1
Hinge 1
Use of Device Problem 1
Missing Value Reason 1
Off-Label Use 1
Unstable 1
Detachment of Device or device Component 1
Physical Resistance / Sticking 1
Contamination / decontamination Problem 1
Fracture 1
Component Missing 1
Total Device Problems 119

Recalls
Manufacturer Recall Class Date Posted
1 Corflex II Jan-04-2016
2 DeRoyal Industries Inc II Dec-19-2019
3 Ossur H / F II Mar-31-2016
4 United Surgical Associates II May-23-2015

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