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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
BIOMET
  SUBSTANTIALLY EQUIVALENT 2
FERNO-WASHINGTON
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
ORTHOPEDIC SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 8
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Device operates differently than expected 11
Fitting problem 6
Failure to Adhere or Bond 5
No Known Device Problem 5
Mechanical jam 4
Difficult to advance 3
Device Issue 3
Break 3
Detachment of device component 2
Sticking 2
Mechanics altered 1
Dislodged or dislocated 1
Bent 1
Disassembly 1
Loose or intermittent connection 1
Failure to align 1
Failure to separate 1
Detachment of device or device component 1
Total Device Problems 52

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 0 0 1 1 0 0 3 1 1 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Allen Medical Systems, Inc. II Mar-18-2013
2 Dick's Sporting Goods II Jan-20-2015
3 Implantech Associates Inc II Feb-20-2014
4 Linvatec Corp. dba ConMed Linvatec II Oct-21-2009
5 Steris Corporation II Jul-22-2013
6 Stryker Endoscopy II May-14-2010
7 Zimmer, Inc. II Jun-14-2013

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