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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device mixer, cement, for clinical use
Regulation Description Cement mixer for clinical use.
Product CodeJDZ
Regulation Number 888.4210
Device Class 1


Premarket Reviews
ManufacturerDecision
DEPUY INTL., LTD.
  SUBSTANTIALLY EQUIVALENT 1
EXACTECH, INC.
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORP.
  1
  SUBSTANTIALLY EQUIVALENT 2
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Metal shedding debris 10
Leak 6
Disassembly 4
Loss of or failure to bond 2
Device or device fragments location unknown 2
Biocompatibility issue 1
Delivery system failure 1
Foreign material present in device 1
Pressure issue 1
Not Applicable 1
No Information 1
Difficult to deploy 1
Electrical issue 1
Component missing 1
Failure to deliver 1
Total Device Problems 34

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

Recalls
Manufacturer Recall Class Date Posted
1 Biomet, Inc. III Jun-30-2009
2 Medtronic Spine LLC, formerly Kyphon Inc II Mar-11-2011
3 Stryker Instruments Div. of Stryker Corporation II Nov-14-2013
4 Stryker Instruments Div. of Stryker Corporation II Jan-25-2012
5 Stryker Instruments Div. of Stryker Corporation II May-01-2008
6 Stryker Instruments Div. of Stryker Corporation II Mar-11-2008

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