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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 162
Component missing 23
Fracture 17
Material fragmentation 16
Disassembly 14
No Information 8
Crack 7
No code available 6
Fitting problem 5
Mechanical jam 5
Detachment of device component 5
Device or device fragments location unknown 3
Difficult to remove 2
Device Cleaning Issue 2
Failure to Adhere or Bond 2
No Known Device Problem 2
Detachment of device or device component 2
Device markings issue 2
Device operates differently than expected 2
Device-device incompatibility 1
Dislodged or dislocated 1
Material deformation 1
Scratched material 1
Torn material 1
Bent 1
Entrapment of device or device component 1
Size incorrect for patient 1
Malposition of device 1
Difficult to insert 1
Mechanical issue 1
Mislabeled 1
Total Device Problems 297

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 3 1 1 0 3 3 2 2 0
Class III 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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