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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device prosthesis, toe (metatarsophalangeal), joint, metal/polymer, semi-constrained
Product CodeLZJ
Device Class Unclassified


Premarket Reviews
ManufacturerDecision
ACCUMED SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 2
ARTHROCARE CORP.
  SUBSTANTIALLY EQUIVALENT 1
ASCENSION ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOMET
  SUBSTANTIALLY EQUIVALENT 2
DOW
  1
KINETIKOS MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
ORTHOPAEDIC BIOSYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
OSTEOMED
  1

Device Problems
Break 1
Unknown (for use when the device problem is not known) 1
Therapeutic or diagnostic output failure 1
Total Device Problems 3

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 0 0 0 0 0 0 1 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Arthrosurface, Inc. II Dec-23-2015

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