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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device orthopedic manual surgical instrument
Regulation Description Orthopedic manual surgical instrument.
Product CodeLXH
Regulation Number 888.4540
Device Class 1


Premarket Reviews
ManufacturerDecision
DEPUY INTL., LTD.
  SUBSTANTIALLY EQUIVALENT 1
DOW
  SUBSTANTIALLY EQUIVALENT 1
KOROS USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
LINVATEC
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
ONYX MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 3
ORTHOPEDIC SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 2
ORTHOVITA
  SUBSTANTIALLY EQUIVALENT 1
RICHARD WOLF
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 2
W.L. GORE & ASSOCIATES,INC
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Break 5389
No code available 999
Fracture 752
Dull 398
Material integrity issue 353
No Information 264
Crack 247
Device operates differently than expected 226
Corrosion 211
Malfunction 198
Component missing 197
Tip breakage 175
Bent 170
Detachment of device component 156
Device, or device fragments remain in patient 148
Mechanical jam 136
Material fragmentation 132
Fitting problem 125
Other (for use when an appropriate device code cannot be identified) 104
Failure to align 104
Unknown (for use when the device problem is not known) 98
Device remains implanted 97
Disassembly 88
Difficult to remove 79
Mechanical issue 78
No Known Device Problem 77
Material deformation 73
Sticking 68
Naturally worn 56
Loose or intermittent connection 54
Detachment of device or device component 53
Device, removal of (non-implant) 49
Use of Device Issue 47
Degraded 45
Component(s), broken 43
Not Applicable 39
Device or device fragments location unknown 33
Device inoperable 33
Implant, removal of 32
Material discolored 32
Failure to Adhere or Bond 31
Difficult to insert 30
Slippage of device or device component 30
Metal shedding debris 25
Dislodged or dislocated 23
Device Issue 22
Connection issue 19
Failure to separate 18
Material separation 17
Component falling 17
Manufacturing or shipping issue associated with device 17
Device Cleaning Issue 16
Improper or incorrect procedure or method 14
Defective item 14
Positioning Issue 13
Disengaged 13
Incorrect measurement 12
Peeled 12
Failure to disconnect 12
Failure to advance 11
Difficult to position 11
Loose 11
Difficult to deploy 11
Mechanics altered 11
Foreign material present in device 10
Difficult to open or close 10
Disconnection 10
Migration of device or device component 10
Misconnection 9
Foreign material 8
Material Distortion 8
Device-device incompatibility 7
Scratched material 7
Component(s), worn 7
Defective component 7
Split 6
Malposition of device 6
Packaging issue 6
Delamination 6
Device markings issue 5
Material twisted 5
Device abrasion from instrument or another object 5
Product quality issue 5
Couple, failure to 5
Loss of or failure to bond 5
Accessory incompatible 4
Contamination during use 4
Intermittent continuity 4
User used incorrect product for intended use 4
Stretched 4
Size incorrect for patient 4
Device damaged prior to use 4
Residue after decontamination 4
Cut in material 4
Human-Device Interface Issue 4
Device disinfection or sterilization issue 4
Device or device component damaged by another device 4
Inadequate user interface 3
Incompatibility problem 3
Output issue 3
Total Device Problems 12272

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 8 14 8 25 13 19 25 18 15 4
Class III 0 1 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Aesculap, Inc. II Nov-19-2013
2 Aesculap, Inc. II Oct-18-2012
3 ArthroCare Medical Corporation II Jan-09-2014
4 Bacterin International, Inc. II Apr-07-2015
5 Biomet Microfixation, Inc. II Aug-01-2011
6 Biomet Microfixation, Inc. II Nov-10-2009
7 Biomet U.K., Ltd. II Mar-19-2012
8 Biomet, Inc. II May-26-2016
9 Biomet, Inc. II Feb-25-2016
10 Biomet, Inc. II Jun-16-2014
11 Biomet, Inc. II Mar-20-2014
12 Biomet, Inc. II Jun-15-2013
13 Biomet, Inc. II Mar-08-2013
14 Biomet, Inc. II Sep-30-2011
15 Biomet, Inc. II Jun-30-2011
16 Biomet, Inc. II Dec-28-2010
17 Biomet, Inc. II Sep-28-2010
18 Biomet, Inc. II Sep-25-2010
19 Biomet, Inc. II Jan-15-2010
20 Biomet, Inc. II Jun-01-2009
21 Biomet, Inc. II Jan-07-2009
22 Biomet, Inc. II Oct-24-2008
23 Biomet, Inc. II Sep-11-2008
24 Biomet, Inc. II Aug-20-2008
25 Biomet, Inc. II Feb-05-2008
26 Biomet, Inc. II Jan-23-2008
27 Biomet, Inc. II Dec-22-2007
28 Biomet, Inc. II Aug-07-2007
29 Captiva Spine, Inc II Apr-21-2015
30 DePuy Mitek, Inc., a Johnson & Johnson Co. II Aug-31-2011
31 DePuy Orthopaedics, Inc. II Oct-07-2015
32 DePuy Orthopaedics, Inc. II Mar-31-2015
33 DePuy Orthopaedics, Inc. II Jan-12-2015
34 DePuy Orthopaedics, Inc. II Jan-05-2015
35 DePuy Orthopaedics, Inc. II Jan-05-2015
36 DePuy Orthopaedics, Inc. II Nov-10-2014
37 DePuy Orthopaedics, Inc. II Oct-08-2014
38 DePuy Orthopaedics, Inc. II Nov-27-2013
39 DePuy Orthopaedics, Inc. II Mar-19-2013
40 DePuy Orthopaedics, Inc. II Apr-16-2012
41 DePuy Orthopaedics, Inc. II Apr-16-2012
42 Depuy Orthopaedics, Inc. II Mar-22-2011
43 Depuy Orthopaedics, Inc. II Feb-22-2011
44 Depuy Orthopaedics, Inc. II Oct-06-2010
45 Ebi, Llc II Sep-17-2013
46 Encore Medical, Lp II Nov-02-2011
47 Encore Medical, Lp II Sep-30-2010
48 Encore Medical, Lp II Aug-02-2010
49 Greatbatch Medical II Jan-30-2013
50 Integra LifeSciences Corp. II Jan-23-2009
51 Kyphon Inc II Sep-18-2008
52 Linvatec Corp. dba ConMed Linvatec II Feb-05-2013
53 Linvatec Corp. dba ConMed Linvatec II Oct-29-2012
54 Linvatec Corp. dba ConMed Linvatec II Aug-06-2012
55 Linvatec Corp. dba ConMed Linvatec II Aug-06-2012
56 Linvatec Corp. dba ConMed Linvatec II Aug-24-2010
57 Medtronic Sofamor Danek USA Inc II Apr-19-2012
58 Medtronic Sofamor Danek USA Inc II Jan-12-2010
59 Medtronic Sofamor Danek USA Inc II Dec-22-2007
60 Microport Orthopedics INC. II Jun-04-2014
61 Orthohelix Surgical Designs Inc II Oct-10-2014
62 Orthohelix Surgical Designs Inc II Apr-15-2010
63 Smith & Nephew Inc II Jun-06-2012
64 Smith & Nephew Inc II Jun-24-2010
65 Smith & Nephew Inc II Aug-04-2009
66 Smith & Nephew Inc II Oct-25-2007
67 Smith & Nephew Inc II Jun-07-2007
68 Smith & Nephew, Inc. Endoscopy Division II Aug-22-2011
69 SpineFrontier, Inc. II Jan-14-2015
70 SpineFrontier, Inc. II Nov-14-2013
71 SpineFrontier, Inc. II Jul-05-2013
72 Stryker Craniomaxillofacial Division II Mar-23-2010
73 Stryker Howmedica Osteonics Corp. II Jul-02-2014
74 Stryker Howmedica Osteonics Corp. II Feb-10-2014
75 Stryker Howmedica Osteonics Corp. II Mar-18-2013
76 Stryker Howmedica Osteonics Corp. II Mar-08-2013
77 Stryker Howmedica Osteonics Corp. II Dec-22-2012
78 Stryker Howmedica Osteonics Corp. II Dec-04-2012
79 Stryker Howmedica Osteonics Corp. II Jul-26-2012
80 Stryker Howmedica Osteonics Corp. II May-17-2012
81 Stryker Howmedica Osteonics Corp. II Mar-22-2012
82 Stryker Howmedica Osteonics Corp. II Jan-18-2012
83 Stryker Howmedica Osteonics Corp. II Mar-16-2011
84 Stryker Howmedica Osteonics Corp. II Jan-19-2011
85 Stryker Howmedica Osteonics Corp. II Dec-27-2010
86 Stryker Howmedica Osteonics Corp. II Nov-26-2010
87 Stryker Howmedica Osteonics Corp. II Oct-13-2010
88 Stryker Howmedica Osteonics Corp. II Aug-02-2010
89 Stryker Howmedica Osteonics Corp. II Aug-02-2010
90 Stryker Howmedica Osteonics Corp. II Aug-02-2010
91 Stryker Howmedica Osteonics Corp. II May-10-2010
92 Stryker Howmedica Osteonics Corp. II Aug-26-2009
93 Stryker Howmedica Osteonics Corp. II Oct-28-2008
94 Stryker Howmedica Osteonics Corp. II Sep-20-2008
95 Stryker Howmedica Osteonics Corp. II Sep-16-2008
96 Stryker Howmedica Osteonics Corp. II Aug-17-2008
97 Stryker Howmedica Osteonics Corp. II Jul-26-2008
98 Stryker Leibinger USA II Feb-27-2007
99 Stryker Spine II Feb-19-2016
100 Stryker Spine II Nov-05-2015
101 Stryker Spine II Dec-16-2014
102 Stryker Spine II Sep-11-2014
103 Stryker Spine II Feb-25-2014
104 Stryker Spine II Nov-21-2013
105 Stryker Spine II Feb-28-2013
106 Stryker Spine II Nov-19-2012
107 Stryker Spine II Oct-29-2012
108 Stryker Spine II Jul-19-2012
109 Stryker Spine II Feb-15-2011
110 Stryker Spine II Jan-12-2011
111 Stryker Spine II Feb-16-2010
112 Stryker Spine II Aug-19-2008
113 Surgical Instrument Service And Savings, Inc. II Jul-01-2013
114 Synthes (USA) Products LLC II Oct-15-2015
115 Synthes (USA) Products LLC II Oct-05-2015
116 Synthes USA (HQ), Inc. II Jun-16-2010
117 Synthes USA HQ, Inc. II Nov-27-2013
118 Synthes USA HQ, Inc. II Nov-26-2013
119 Synthes USA HQ, Inc. II Nov-25-2013
120 Synthes USA HQ, Inc. II Nov-22-2013
121 Synthes USA HQ, Inc. II Nov-13-2013
122 Synthes USA HQ, Inc. II Sep-26-2013
123 Synthes USA HQ, Inc. II Jul-29-2013
124 Synthes USA HQ, Inc. II Apr-05-2013
125 Synthes, Inc. II Mar-10-2015
126 Synthes, Inc. II Jul-21-2014
127 Synthes, Inc. II Feb-20-2014
128 Synthes, Inc. II Feb-16-2014
129 Tedan Surgical Innovations Llc II Sep-14-2012
130 Wright Medical Technology Inc II Jun-07-2010
131 Wright Medical Technology Inc II Apr-28-2009
132 Wright Medical Technology Inc II Sep-17-2008
133 Zimmer Gmbh II Aug-02-2016
134 Zimmer Gmbh II Apr-27-2015
135 Zimmer Inc. II Jan-10-2011
136 Zimmer Inc. II Dec-13-2010
137 Zimmer Inc. II Oct-15-2010
138 Zimmer Inc. II Aug-26-2010
139 Zimmer Inc. II Feb-27-2009
140 Zimmer Inc. III Sep-17-2008
141 Zimmer Inc. II Sep-11-2008
142 Zimmer Inc. II Dec-15-2007
143 Zimmer Inc. II Mar-29-2007
144 Zimmer, Inc. II Dec-10-2015
145 Zimmer, Inc. II May-29-2015
146 Zimmer, Inc. II Aug-26-2014
147 Zimmer, Inc. II Aug-22-2014
148 Zimmer, Inc. II Aug-14-2014
149 Zimmer, Inc. II Aug-12-2013
150 Zimmer, Inc. II Jul-01-2013

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