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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 6678
No code available 1214
Fracture 933
Dull 408
Material integrity issue 402
Crack 373
No Information 310
Device operates differently than expected 271
Component missing 248
Bent 234
Corrosion 218
Malfunction 198
Fitting problem 181
Material fragmentation 176
Tip breakage 175
Detachment of device component 163
Mechanical jam 162
Device, or device fragments remain in patient 148
Failure to align 131
Mechanical issue 114
Disassembly 111
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 94
Material deformation 93
Difficult to remove 87
Detachment of device or device component 82
Sticking 69
Naturally worn 61
Use of Device Issue 58
Loose or intermittent connection 55
Degraded 50
Failure to Adhere or Bond 49
Device, removal of (non-implant) 49
Component(s), broken 43
Device inoperable 41
Not Applicable 39
Device or device fragments location unknown 34
Difficult to insert 33
Material discolored 32
Implant, removal of 32
Slippage of device or device component 30
Metal shedding debris 28
Connection issue 27
Dislodged or dislocated 27
Failure to separate 25
Device Issue 23
Device Cleaning Issue 23
Component falling 19
Misconnection 19
Failure to disconnect 18
Material separation 18
Manufacturing or shipping issue associated with device 17
Positioning Issue 16
Improper or incorrect procedure or method 16
Peeled 15
Defective item 15
Disengaged 13
Difficult to open or close 13
Material twisted 12
Device or device component damaged by another device 12
Mechanics altered 12
Incorrect measurement 12
Difficult to position 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
Device markings issue 8
Material Distortion 8
Device-device incompatibility 8
Scratched material 8
Foreign material 8
Component(s), worn 7
Split 7
Defective component 7
Output issue 7
Packaging issue 7
Malposition of device 7
Delamination 6
Unintended movement 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
Residue after decontamination 5
Product quality issue 5
Size incorrect for patient 5
Device disinfection or sterilization issue 5
Human-Device Interface Issue 5
Stretched 4
User used incorrect product for intended use 4
Unraveled material 4
Structural problem 4
Cut in material 4
Entrapment of device or device component 4
Flaked 4
Total Device Problems 14808

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

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