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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 6957
No code available 1255
Fracture 1015
Material integrity issue 434
Dull 414
Crack 411
No Information 317
Device operates differently than expected 301
Bent 255
Component missing 239
Corrosion 217
Malfunction 198
Material fragmentation 197
Fitting problem 183
Mechanical jam 177
Tip breakage 175
Detachment of device component 163
Device, or device fragments remain in patient 148
Failure to align 135
Disassembly 129
Mechanical issue 120
Other (for use when an appropriate device code cannot be identified) 105
Material deformation 100
No Known Device Problem 98
Unknown (for use when the device problem is not known) 98
Device remains implanted 97
Difficult to remove 90
Detachment of device or device component 89
Naturally worn 73
Sticking 69
Use of Device Issue 59
Loose or intermittent connection 57
Degraded 51
Device, removal of (non-implant) 49
Failure to Adhere or Bond 48
Component(s), broken 43
Device inoperable 41
Not Applicable 39
Material discolored 37
Difficult to insert 34
Device or device fragments location unknown 33
Implant, removal of 32
Slippage of device or device component 30
Connection issue 30
Failure to separate 28
Metal shedding debris 27
Dislodged or dislocated 25
Device Issue 23
Device Cleaning Issue 23
Misconnection 22
Component falling 18
Failure to disconnect 18
Material separation 17
Peeled 17
Manufacturing or shipping issue associated with device 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
Disengaged 13
Incorrect measurement 12
Difficult to position 12
Failure to advance 12
Migration of device or device component 11
Loose 11
Disconnection 11
Difficult to deploy 11
Material twisted 11
Mechanics altered 11
Foreign material present in device 10
Device markings issue 9
Material Distortion 9
Packaging issue 9
Scratched material 8
Device-device incompatibility 8
Foreign material 8
Device abrasion from instrument or another object 8
Defective component 8
Split 7
Component(s), worn 7
Malposition of device 7
Output issue 7
Unintended movement 6
Delamination 6
Loss of or failure to bond 6
Device damaged prior to use 6
Output above specifications 6
Product quality issue 5
Size incorrect for patient 5
Residue after decontamination 5
Couple, failure to 5
Component incompatible 4
Contamination during use 4
Intermittent continuity 4
Accessory incompatible 4
Blockage within device or device component 4
Entrapment of device or device component 4
Flaked 4
Unraveled material 4
Total Device Problems 15454

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

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