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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device apparatus, traction, non-powered
Regulation Description Nonpowered orthopedic traction apparatus and accessories.
Product CodeHST
Regulation Number 888.5850
Device Class 1


Premarket Reviews
ManufacturerDecision
STL INTERNATIONAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
STL INTL
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Break 16
Device Operates Differently Than Expected 14
Positioning Failure 9
Adverse Event Without Identified Device or Use Problem 8
Fitting Problem 8
Mechanical Jam 8
Failure To Adhere Or Bond 7
Detachment Of Device Component 6
Device-Device Incompatibility 5
Failure to Align 4
Material Twisted/Bent 4
Use of Device Problem 4
Difficult to Advance 3
Sticking 3
Positioning Problem 3
Material Separation 2
Fracture 2
Loose or Intermittent Connection 1
Separation Failure 1
Mechanics Altered 1
Detachment of Device or Device Component 1
Naturally Worn 1
Insufficient Information 1
Mechanical Problem 1
Material Integrity Problem 1
Device Issue 1
Bent 1
Unintended Movement 1
Device Fell 1
Disassembly 1
Device Dislodged or Dislocated 1
Material Deformation 1
Total Device Problems 121

Recalls
Manufacturer Recall Class Date Posted
1 Allen Medical Systems, Inc. II Feb-14-2017
2 Allen Medical Systems, Inc. II Dec-29-2016
3 Dick's Sporting Goods II Jan-20-2015

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