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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 6537
No code available 1192
Fracture 887
Dull 408
Material integrity issue 393
Crack 356
No Information 303
Device operates differently than expected 263
Component missing 242
Bent 224
Corrosion 216
Malfunction 198
Fitting problem 178
Tip breakage 175
Material fragmentation 168
Detachment of device component 163
Mechanical jam 156
Device, or device fragments remain in patient 148
Failure to align 127
Disassembly 107
Mechanical issue 107
Other (for use when an appropriate device code cannot be identified) 105
Unknown (for use when the device problem is not known) 101
Device remains implanted 97
No Known Device Problem 93
Material deformation 88
Difficult to remove 86
Detachment of device or device component 78
Sticking 69
Naturally worn 61
Use of Device Issue 57
Loose or intermittent connection 54
Degraded 49
Device, removal of (non-implant) 49
Component(s), broken 43
Failure to Adhere or Bond 42
Device inoperable 40
Not Applicable 39
Device or device fragments location unknown 34
Implant, removal of 32
Material discolored 32
Difficult to insert 32
Slippage of device or device component 30
Metal shedding debris 28
Dislodged or dislocated 27
Connection issue 25
Failure to separate 25
Device Issue 23
Device Cleaning Issue 23
Component falling 19
Misconnection 19
Material separation 18
Failure to disconnect 17
Manufacturing or shipping issue associated with device 17
Improper or incorrect procedure or method 16
Defective item 15
Positioning Issue 15
Peeled 13
Disengaged 13
Incorrect measurement 12
Difficult to position 12
Device or device component damaged by another device 12
Mechanics altered 12
Difficult to open or close 12
Failure to advance 11
Migration of device or device component 11
Loose 11
Disconnection 11
Difficult to deploy 11
Foreign material present in device 10
Material twisted 9
Material Distortion 8
Device-device incompatibility 8
Foreign material 8
Component(s), worn 7
Split 7
Malposition of device 7
Defective component 7
Scratched material 7
Output issue 7
Packaging issue 7
Delamination 6
Device markings issue 6
Device damaged prior to use 6
Loss of or failure to bond 6
Couple, failure to 5
Device abrasion from instrument or another object 5
Size incorrect for patient 5
Residue after decontamination 5
Product quality issue 5
Human-Device Interface Issue 5
Device disinfection or sterilization issue 5
Unintended movement 5
User used incorrect product for intended use 4
Unraveled material 4
Stretched 4
Structural problem 4
Cut in material 4
Entrapment of device or device component 4
Flaked 4
Total Device Problems 14471

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 8 14 8 25 13 19 25 18 15 12 1
Class III 0 1 0 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 Amendia, Inc II Dec-22-2016
4 ArthroCare Medical Corporation II Jan-09-2014
5 Bacterin International, Inc. II Apr-07-2015
6 Biomet Microfixation, Inc. II Aug-01-2011
7 Biomet Microfixation, Inc. II Nov-10-2009
8 Biomet U.K., Ltd. II Mar-19-2012
9 Biomet, Inc. II May-26-2016
10 Biomet, Inc. II Feb-25-2016
11 Biomet, Inc. II Jun-16-2014
12 Biomet, Inc. II Mar-20-2014
13 Biomet, Inc. II Jun-15-2013
14 Biomet, Inc. II Mar-08-2013
15 Biomet, Inc. II Sep-30-2011
16 Biomet, Inc. II Jun-30-2011
17 Biomet, Inc. II Dec-28-2010
18 Biomet, Inc. II Sep-28-2010
19 Biomet, Inc. II Sep-25-2010
20 Biomet, Inc. II Jan-15-2010
21 Biomet, Inc. II Jun-01-2009
22 Biomet, Inc. II Jan-07-2009
23 Biomet, Inc. II Oct-24-2008
24 Biomet, Inc. II Sep-11-2008
25 Biomet, Inc. II Aug-20-2008
26 Biomet, Inc. II Feb-05-2008
27 Biomet, Inc. II Jan-23-2008
28 Biomet, Inc. II Dec-22-2007
29 Biomet, Inc. II Aug-07-2007
30 Captiva Spine, Inc II Apr-21-2015
31 Cardinal Health 200, LLC II Oct-11-2016
32 DePuy Mitek, Inc., a Johnson & Johnson Co. II Aug-31-2011
33 DePuy Orthopaedics, Inc. II Oct-07-2015
34 DePuy Orthopaedics, Inc. II Mar-31-2015
35 DePuy Orthopaedics, Inc. II Jan-12-2015
36 DePuy Orthopaedics, Inc. II Jan-05-2015
37 DePuy Orthopaedics, Inc. II Jan-05-2015
38 DePuy Orthopaedics, Inc. II Nov-10-2014
39 DePuy Orthopaedics, Inc. II Oct-08-2014
40 DePuy Orthopaedics, Inc. II Nov-27-2013
41 DePuy Orthopaedics, Inc. II Mar-19-2013
42 DePuy Orthopaedics, Inc. II Apr-16-2012
43 DePuy Orthopaedics, Inc. II Apr-16-2012
44 Depuy Orthopaedics, Inc. II Mar-22-2011
45 Depuy Orthopaedics, Inc. II Feb-22-2011
46 Depuy Orthopaedics, Inc. II Oct-06-2010
47 Ebi, Llc II Sep-17-2013
48 Encore Medical, Lp II Nov-02-2011
49 Encore Medical, Lp II Sep-30-2010
50 Encore Medical, Lp II Aug-02-2010
51 Greatbatch Medical II Jan-30-2013
52 Integra LifeSciences Corp. II Jan-23-2009
53 Kyphon Inc II Sep-18-2008
54 LDR Spine USA, Inc. II Oct-05-2016
55 Limacorporate S.p.A II Aug-31-2016
56 Linvatec Corp. dba ConMed Linvatec II Feb-05-2013
57 Linvatec Corp. dba ConMed Linvatec II Oct-29-2012
58 Linvatec Corp. dba ConMed Linvatec II Aug-06-2012
59 Linvatec Corp. dba ConMed Linvatec II Aug-06-2012
60 Linvatec Corp. dba ConMed Linvatec II Aug-24-2010
61 Medtronic Sofamor Danek USA Inc II Apr-19-2012
62 Medtronic Sofamor Danek USA Inc II Jan-12-2010
63 Medtronic Sofamor Danek USA Inc II Dec-22-2007
64 Microport Orthopedics INC. II Jun-04-2014
65 Orthohelix Surgical Designs Inc II Oct-10-2014
66 Orthohelix Surgical Designs Inc II Apr-15-2010
67 Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables II Dec-22-2016
68 Smith & Nephew Inc II Jun-06-2012
69 Smith & Nephew Inc II Jun-24-2010
70 Smith & Nephew Inc II Aug-04-2009
71 Smith & Nephew Inc II Oct-25-2007
72 Smith & Nephew Inc II Jun-07-2007
73 Smith & Nephew, Inc. Endoscopy Division II Aug-22-2011
74 SpineFrontier, Inc. II Jan-14-2015
75 SpineFrontier, Inc. II Nov-14-2013
76 SpineFrontier, Inc. II Jul-05-2013
77 Stryker Craniomaxillofacial Division II Mar-23-2010
78 Stryker Howmedica Osteonics Corp. II Jan-12-2017
79 Stryker Howmedica Osteonics Corp. II Jul-02-2014
80 Stryker Howmedica Osteonics Corp. II Feb-10-2014
81 Stryker Howmedica Osteonics Corp. II Mar-18-2013
82 Stryker Howmedica Osteonics Corp. II Mar-08-2013
83 Stryker Howmedica Osteonics Corp. II Dec-22-2012
84 Stryker Howmedica Osteonics Corp. II Dec-04-2012
85 Stryker Howmedica Osteonics Corp. II Jul-26-2012
86 Stryker Howmedica Osteonics Corp. II May-17-2012
87 Stryker Howmedica Osteonics Corp. II Mar-22-2012
88 Stryker Howmedica Osteonics Corp. II Jan-18-2012
89 Stryker Howmedica Osteonics Corp. II Mar-16-2011
90 Stryker Howmedica Osteonics Corp. II Jan-19-2011
91 Stryker Howmedica Osteonics Corp. II Dec-27-2010
92 Stryker Howmedica Osteonics Corp. II Nov-26-2010
93 Stryker Howmedica Osteonics Corp. II Oct-13-2010
94 Stryker Howmedica Osteonics Corp. II Aug-02-2010
95 Stryker Howmedica Osteonics Corp. II Aug-02-2010
96 Stryker Howmedica Osteonics Corp. II Aug-02-2010
97 Stryker Howmedica Osteonics Corp. II May-10-2010
98 Stryker Howmedica Osteonics Corp. II Aug-26-2009
99 Stryker Howmedica Osteonics Corp. II Oct-28-2008
100 Stryker Howmedica Osteonics Corp. II Sep-20-2008
101 Stryker Howmedica Osteonics Corp. II Sep-16-2008
102 Stryker Howmedica Osteonics Corp. II Aug-17-2008
103 Stryker Howmedica Osteonics Corp. II Jul-26-2008
104 Stryker Leibinger USA II Feb-27-2007
105 Stryker Spine II Feb-19-2016
106 Stryker Spine II Nov-05-2015
107 Stryker Spine II Dec-16-2014
108 Stryker Spine II Sep-11-2014
109 Stryker Spine II Feb-25-2014
110 Stryker Spine II Nov-21-2013
111 Stryker Spine II Feb-28-2013
112 Stryker Spine II Nov-19-2012
113 Stryker Spine II Oct-29-2012
114 Stryker Spine II Jul-19-2012
115 Stryker Spine II Feb-15-2011
116 Stryker Spine II Jan-12-2011
117 Stryker Spine II Feb-16-2010
118 Stryker Spine II Aug-19-2008
119 Surgical Instrument Service And Savings, Inc. II Jul-01-2013
120 Synthes (USA) Products LLC II Nov-19-2016
121 Synthes (USA) Products LLC II Oct-15-2015
122 Synthes (USA) Products LLC II Oct-05-2015
123 Synthes USA (HQ), Inc. II Jun-16-2010
124 Synthes USA HQ, Inc. II Nov-27-2013
125 Synthes USA HQ, Inc. II Nov-26-2013
126 Synthes USA HQ, Inc. II Nov-25-2013
127 Synthes USA HQ, Inc. II Nov-22-2013
128 Synthes USA HQ, Inc. II Nov-13-2013
129 Synthes USA HQ, Inc. II Sep-26-2013
130 Synthes USA HQ, Inc. II Jul-29-2013
131 Synthes USA HQ, Inc. II Apr-05-2013
132 Synthes, Inc. II Mar-10-2015
133 Synthes, Inc. II Jul-21-2014
134 Synthes, Inc. II Feb-20-2014
135 Synthes, Inc. II Feb-16-2014
136 Tedan Surgical Innovations Llc II Sep-14-2012
137 Thayer Intellectual Property, Inc. II Dec-03-2016
138 Wright Medical Technology Inc II Jun-07-2010
139 Wright Medical Technology Inc II Apr-28-2009
140 Wright Medical Technology Inc II Sep-17-2008
141 Zimmer Biomet, Inc. II Oct-14-2016
142 Zimmer Gmbh II Aug-02-2016
143 Zimmer Gmbh II Apr-27-2015
144 Zimmer Inc. II Jan-10-2011
145 Zimmer Inc. II Dec-13-2010
146 Zimmer Inc. II Oct-15-2010
147 Zimmer Inc. II Aug-26-2010
148 Zimmer Inc. II Feb-27-2009
149 Zimmer Inc. III Sep-17-2008
150 Zimmer Inc. II Sep-11-2008
151 Zimmer Inc. II Dec-15-2007
152 Zimmer Inc. II Mar-29-2007
153 Zimmer, Inc. II Dec-10-2015
154 Zimmer, Inc. II May-29-2015
155 Zimmer, Inc. II Aug-26-2014
156 Zimmer, Inc. II Aug-22-2014
157 Zimmer, Inc. II Aug-14-2014
158 Zimmer, Inc. II Aug-12-2013
159 Zimmer, Inc. II Jul-01-2013

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