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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device lavage, jet
Regulation Description Jet lavage.
Product CodeFQH
Regulation Number 880.5475
Device Class 2


Premarket Reviews
ManufacturerDecision
BIO-MEDICAL DEVICES, INC.
  SUBSTANTIALLY EQUIVALENT 1
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 2
ERBE ELEKTROMEDIZIN GMBH
  SUBSTANTIALLY EQUIVALENT 3
ETHICON
  SUBSTANTIALLY EQUIVALENT 1
HYDROCISION
  SUBSTANTIALLY EQUIVALENT 3
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 3
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 3
XOMED, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Break 16
Foreign material present in device 16
Overheating of device or device component 13
Biocompatibility issue 9
Leak 8
No Known Device Problem 8
Disassembly 7
Fracture 4
Detachment of device or device component 3
Device operates differently than expected 3
Fluid leak 3
No Information 2
Burst 2
Detachment of device component 2
Device, or device fragments remain in patient 2
Material rupture 2
Use of Device Issue 2
Improper or incorrect procedure or method 1
Defective component 1
Tear, rip or hole in device packaging 1
Battery issue 1
Corrosion 1
Inability to irrigate 1
Electrical issue 1
Noise, Audible 1
Device emits odor 1
Packaging issue 1
Temperature issue 1
Not Applicable 1
Total Device Problems 114

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

Recalls
Manufacturer Recall Class Date Posted
1 Coloplast Corp II Apr-03-2008
2 EXP Pharmaceutical Services Corp II Jul-24-2015
3 Stryker Instruments Div. of Stryker Corporation II Jul-13-2015
4 Stryker Instruments Division of Stryker Corporation II Jan-25-2011
5 Zimmer Inc. II Jul-23-2009
6 Zimmer Orthopaedic Surgical Products II Mar-06-2008

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