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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device guide, surgical, instrument
Regulation Description Manual surgical instrument for general use.
Product CodeFZX
Regulation Number 878.4800
Device Class 1


Premarket Reviews
ManufacturerDecision
ASPEN LABORATORIES
  SUBSTANTIALLY EQUIVALENT 1
BIOSEARCH MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 2
CIVCO
  SUBSTANTIALLY EQUIVALENT 1
MEADOX
  SUBSTANTIALLY EQUIVALENT 1
MEDCARE
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Failure to align 102
Break 92
Device operates differently than expected 46
Fitting problem 43
Mechanical jam 28
Material fragmentation 18
Fracture 15
Sticking 13
Bent 12
Component missing 11
Difficult to remove 10
Use of Device Issue 9
Failure to Adhere or Bond 9
Dull 7
Material deformation 7
Positioning Issue 5
Insulation, detached 5
Difficult to position 4
No Known Device Problem 4
No Information 3
No code available 3
Naturally worn 3
Detachment of device or device component 3
Dislodged or dislocated 3
Unknown (for use when the device problem is not known) 3
Failure to advance 3
Loose or intermittent connection 3
Detachment of device component 3
Crack 3
Material frayed 2
Unsealed device packaging 2
Failure to separate 2
Device or device fragments location unknown 2
Malposition of device 2
Material Distortion 2
Material twisted 1
Device-device incompatibility 1
Difficult to advance 1
Scratched material 1
Unintended movement 1
Blocked connection 1
Device markings issue 1
Failure to auto stop 1
Foreign material present in device 1
Incorrect device or component shipped 1
Manufacturing or shipping issue associated with device 1
Device handling issue 1
Device, removal of (non-implant) 1
Failure to disconnect 1
Malfunction 1
Residue after decontamination 1
Metal shedding debris 1
Material separation 1
Peeled 1
Mechanical issue 1
Mislabeled 1
Nonstandard device or device component 1
Overheating of device or device component 1
Disassembly 1
Entrapment of device or device component 1
Connection error 1
Continuous firing 1
Collapse 1
Total Device Problems 510

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 1 0 2 1 4 2 5 2
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Biomet, Inc. II May-26-2016
2 Biomet, Inc. II Nov-22-2013
3 Biomet, Inc. II Oct-20-2011
4 Biomet, Inc. II Mar-28-2011
5 Biomet, Inc. II Nov-19-2009
6 Integra Life Sci. II Sep-14-2012
7 Omnilife Science Inc. II Aug-24-2015
8 Orthofix, Inc II Jun-19-2015
9 SpineFrontier, Inc. II Aug-02-2013
10 Synthes (USA) Products LLC II Mar-31-2016
11 Synthes, Inc. II Jun-15-2015
12 Synthes, Inc. II Mar-16-2015
13 Synthes, Inc. II Feb-19-2014
14 X Spine Systems Inc II Aug-01-2014
15 Zimmer, Inc. II Sep-30-2015
16 Zimmer, Inc. II Dec-27-2013
17 Zimmer, Inc. II Dec-06-2013

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