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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 199
Failure to align 185
Fitting problem 113
Device operates differently than expected 88
Mechanical jam 54
Bent 51
Material fragmentation 47
Fracture 31
Failure to Adhere or Bond 25
Sticking 19
Material deformation 19
Component missing 19
Dull 13
Difficult to remove 12
Unintended movement 11
Failure to separate 10
Use of Device Issue 9
Difficult to position 8
No Known Device Problem 7
Positioning Issue 6
Crack 5
Insulation, detached 5
Detachment of device component 4
Difficult to insert 4
Naturally worn 4
Material Distortion 4
Detachment of device or device component 4
No code available 4
No Information 3
Dislodged or dislocated 3
Failure to advance 3
Peeled 3
Unknown (for use when the device problem is not known) 3
Loose or intermittent connection 3
Disassembly 3
Entrapment of device or device component 2
Material frayed 2
Metal shedding debris 2
Unsealed device packaging 2
Misassembled 2
Device or device fragments location unknown 2
Malposition of device 2
Buckled material 2
Device markings issue 2
Difficult to advance 2
Difficult to open or remove packaging material 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
Scratched material 1
Component or accessory incompatibility 1
Blocked connection 1
Device or device component damaged by another device 1
Device packaging compromised 1
Device-device incompatibility 1
Device, removal of (non-implant) 1
Failure to disconnect 1
Malfunction 1
Residue after decontamination 1
Mislabeled 1
Nonstandard device or device component 1
Overheating of device or device component 1
Material separation 1
Device inoperable 1
Incorrect measurement 1
Mechanical issue 1
Connection error 1
Continuous firing 1
Corrosion 1
Collapse 1
Device handling issue 1
Total Device Problems 1030

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 1
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 Cook Inc. II Jun-14-2017
7 Integra Life Sci. II Sep-14-2012
8 Omnilife Science Inc. II Aug-24-2015
9 Orthofix, Inc II Jun-19-2015
10 SpineFrontier, Inc. II Aug-02-2013
11 Synthes (USA) Products LLC II Jul-15-2016
12 Synthes (USA) Products LLC II Mar-31-2016
13 Synthes, Inc. II Jun-15-2015
14 Synthes, Inc. II Mar-16-2015
15 Synthes, Inc. II Feb-19-2014
16 X Spine Systems Inc II Aug-01-2014
17 Zimmer Biomet, Inc. II Oct-14-2016
18 Zimmer, Inc. II Sep-30-2015
19 Zimmer, Inc. II Dec-27-2013
20 Zimmer, Inc. II Dec-06-2013

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