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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device template
Regulation Description Template for clinical use.
Product CodeHWT
Regulation Number 888.4800
Device Class 1


Premarket Reviews
ManufacturerDecision
3M COMPANY
  SUBSTANTIALLY EQUIVALENT 1
BIOMET
  SUBSTANTIALLY EQUIVALENT 1
DEPUY INTL., LTD.
  SUBSTANTIALLY EQUIVALENT 2
INTEGRATED MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
ORTHOPEDIC SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Break 331
Crack 45
Fracture 30
Component missing 28
No code available 26
Material fragmentation 18
Disassembly 17
No Information 12
Residue after decontamination 10
No Known Device Problem 9
Fitting problem 7
Bent 7
Detachment of device component 5
Mechanical jam 5
Device operates differently than expected 5
Difficult to remove 4
Difficult to insert 3
Device or device fragments location unknown 3
Malposition of device 3
Detachment of device or device component 3
Material integrity issue 3
Unintended movement 3
Failure to separate 2
Device markings issue 2
Failure to Adhere or Bond 2
Device Cleaning Issue 2
Size incorrect for patient 2
Unstable 2
Migration of device or device component 2
Mislabeled 1
Entrapment of device or device component 1
Mechanical issue 1
Device-device incompatibility 1
Dislodged or dislocated 1
Material deformation 1
Material Distortion 1
Naturally worn 1
Scratched material 1
Torn material 1
Total Device Problems 601

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 0
Class II 0 3 1 1 0 3 3 2 2 0 0
Class III 0 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Aesculap Implant Systems LLC II Jul-31-2012
2 Biomet, Inc. II Jul-14-2015
3 Biomet, Inc. II Oct-16-2014
4 Biomet, Inc. II Mar-28-2008
5 DePuy Orthopaedics, Inc. II Apr-09-2014
6 DePuy Orthopaedics, Inc. II Jun-07-2013
7 Encore Medical, Lp II Jul-27-2015
8 Stryker Howmedica Osteonics Corp. II Sep-16-2008
9 Stryker Howmedica Osteonics Corp. II Aug-23-2008
10 Waldemar Link GmbH & Co. KG (Corp. Hq.) II Aug-26-2013
11 Zimmer Inc. II Dec-14-2010
12 Zimmer Inc. II Jan-23-2009
13 Zimmer, Inc. II Dec-06-2013
14 Zimmer, Inc. II Nov-19-2012
15 Zimmer, Inc. II Sep-28-2012

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