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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
Break 167
Failure to align 145
Fitting problem 91
Device operates differently than expected 77
Mechanical jam 43
Bent 41
Material fragmentation 37
Fracture 28
Material deformation 18
Component missing 17
Sticking 17
Failure to Adhere or Bond 16
Dull 12
Difficult to remove 11
Use of Device Issue 9
Failure to separate 9
Difficult to position 8
Unintended movement 7
No Known Device Problem 6
Positioning Issue 6
Insulation, detached 5
Crack 4
Detachment of device component 4
Naturally worn 4
Detachment of device or device component 4
Material Distortion 4
Dislodged or dislocated 3
No Information 3
No code available 3
Failure to advance 3
Disassembly 3
Loose or intermittent connection 3
Peeled 3
Unknown (for use when the device problem is not known) 3
Metal shedding debris 2
Unsealed device packaging 2
Misassembled 2
Entrapment of device or device component 2
Material frayed 2
Device or device fragments location unknown 2
Malposition of device 2
Buckled material 2
Component or accessory incompatibility 1
Blocked connection 1
Device packaging compromised 1
Device-device incompatibility 1
Difficult to advance 1
Device, removal of (non-implant) 1
Failure to disconnect 1
Malfunction 1
Residue after decontamination 1
Device handling issue 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
Material integrity issue 1
Material twisted 1
Incorrect measurement 1
Mechanical issue 1
Connection error 1
Continuous firing 1
Corrosion 1
Collapse 1
Mislabeled 1
Nonstandard device or device component 1
Overheating of device or device component 1
Material separation 1
Device inoperable 1
Scratched material 1
Total Device Problems 859

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 0
Class II 0 0 1 0 2 1 4 2 5 4 0
Class III 0 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 Jul-15-2016
11 Synthes (USA) Products LLC II Mar-31-2016
12 Synthes, Inc. II Jun-15-2015
13 Synthes, Inc. II Mar-16-2015
14 Synthes, Inc. II Feb-19-2014
15 X Spine Systems Inc II Aug-01-2014
16 Zimmer Biomet, Inc. II Oct-14-2016
17 Zimmer, Inc. II Sep-30-2015
18 Zimmer, Inc. II Dec-27-2013
19 Zimmer, Inc. II Dec-06-2013

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