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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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Device instrument, surgical, orthopedic, pneumatic powered & accessory/attachment
Product CodeHSZ
Device Class Unclassified


Premarket Reviews
ManufacturerDecision
3M COMPANY
  SUBSTANTIALLY EQUIVALENT 1
ARTHREX, INC.
  SUBSTANTIALLY EQUIVALENT 1
ETHICON
  SUBSTANTIALLY EQUIVALENT 1
KARL STORZ GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL INSTRUMENT
  SUBSTANTIALLY EQUIVALENT 1
ORTHOPEDIC SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
RICHARD WOLF
  SUBSTANTIALLY EQUIVALENT 1
THE ANSPACH EFFORT, INC.
  SUBSTANTIALLY EQUIVALENT 4
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Fracture 3
Break 3
Use of Device Issue 2
Device operates differently than expected 2
Maintenance does not comply to manufacturers recommendations 1
No Known Device Problem 1
Detachment of device component 1
Air leak 1
Total Device Problems 14

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 1 2 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 The Anspach Effort, Inc. II Jul-03-2014
2 The Anspach Effort, Inc. II Jan-09-2014
3 The Anspach Effort, Inc. II Nov-13-2013

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