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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 3
Crack 1
Fracture 1
Mislabeled 1
Total Device Problems 6

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 0 0 0
Class II 0 3 1 1 0 3 1
Class III 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 Mar-28-2008
3 DePuy Orthopaedics, Inc. II Jun-07-2013
4 Stryker Howmedica Osteonics Corp. II Sep-16-2008
5 Stryker Howmedica Osteonics Corp. II Aug-23-2008
6 Zimmer Inc. II Dec-14-2010
7 Zimmer Inc. II Jan-23-2009
8 Zimmer, Inc. II Nov-19-2012
9 Zimmer, Inc. II Sep-28-2012

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