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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 7187
No code available 1280
Fracture 1087
Material integrity issue 457
Crack 437
Dull 416
No Information 323
Device operates differently than expected 322
Bent 267
Component missing 245
Material fragmentation 219
Corrosion 218
Malfunction 198
Fitting problem 195
Mechanical jam 190
Mechanical issue 183
Tip breakage 175
Detachment of device component 167
Device, or device fragments remain in patient 148
Failure to align 147
Disassembly 141
Other (for use when an appropriate device code cannot be identified) 105
Material deformation 105
No Known Device Problem 102
Unknown (for use when the device problem is not known) 98
Device remains implanted 97
Difficult to remove 92
Detachment of device or device component 92
Naturally worn 74
Sticking 69
Use of Device Issue 63
Loose or intermittent connection 59
Degraded 51
Failure to Adhere or Bond 51
Device, removal of (non-implant) 49
Component(s), broken 43
Device inoperable 41
Not Applicable 39
Connection issue 37
Material discolored 37
Difficult to insert 35
Slippage of device or device component 35
Failure to separate 33
Device or device fragments location unknown 33
Implant, removal of 32
Dislodged or dislocated 30
Metal shedding debris 27
Device Issue 23
Device Cleaning Issue 23
Misconnection 22
Manufacturing or shipping issue associated with device 19
Component falling 18
Failure to disconnect 18
Material separation 17
Peeled 17
Defective item 16
Device or device component damaged by another device 15
Positioning Issue 15
Improper or incorrect procedure or method 15
Difficult to open or close 14
Residue after decontamination 13
Difficult to position 13
Incorrect measurement 13
Disengaged 13
Migration of device or device component 12
Defective component 12
Failure to advance 12
Loose 11
Disconnection 11
Difficult to deploy 11
Material twisted 11
Mechanics altered 11
Device markings issue 10
Foreign material present in device 10
Material Distortion 9
Packaging issue 9
Scratched material 8
Device-device incompatibility 8
Device abrasion from instrument or another object 8
Foreign material 8
Misassembled 8
Output above specifications 7
Split 7
Component(s), worn 7
Malposition of device 7
Unintended movement 7
Output issue 7
Device handling issue 6
Delamination 6
Loss of or failure to bond 6
Blockage within device or device component 6
Device damaged prior to use 6
Product quality issue 6
Size incorrect for patient 5
Couple, failure to 5
Contamination during use 5
Intermittent continuity 4
Component incompatible 4
Accessory incompatible 4
Flaked 4
Total Device Problems 16093

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 13
Class III 0 1 0 0 0 0 0 0 0 0 0

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

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