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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 7807
No code available 1428
Fracture 1287
Crack 534
Material integrity issue 497
Dull 419
Device operates differently than expected 378
No Information 341
Bent 310
Component missing 262
Material fragmentation 236
Mechanical jam 232
Corrosion 224
Mechanical issue 208
Fitting problem 207
Malfunction 198
Detachment of device component 178
Tip breakage 175
Failure to align 156
Disassembly 154
Device, or device fragments remain in patient 148
Material deformation 130
No Known Device Problem 118
Other (for use when an appropriate device code cannot be identified) 105
Difficult to remove 99
Unknown (for use when the device problem is not known) 98
Device remains implanted 97
Detachment of device or device component 97
Naturally worn 83
Sticking 76
Loose or intermittent connection 76
Failure to Adhere or Bond 67
Use of Device Issue 67
Connection issue 63
Degraded 52
Device, removal of (non-implant) 49
Difficult to insert 45
Component(s), broken 43
Device inoperable 42
Failure to separate 41
Material discolored 40
Not Applicable 39
Slippage of device or device component 35
Device or device fragments location unknown 33
Dislodged or dislocated 33
Implant, removal of 32
Misconnection 30
Metal shedding debris 29
Device Issue 28
Device Cleaning Issue 26
Defective item 25
Scratched material 25
Manufacturing or shipping issue associated with device 19
Difficult to position 19
Peeled 18
Failure to disconnect 18
Component falling 18
Material separation 17
Device or device component damaged by another device 17
Improper or incorrect procedure or method 16
Residue after decontamination 15
Migration of device or device component 15
Difficult to open or close 15
Positioning Issue 15
Defective component 14
Incorrect measurement 14
Disengaged 13
Material twisted 13
Device markings issue 12
Failure to advance 12
Misassembled 11
Nonstandard device or device component 11
Loose 11
Disconnection 11
Difficult to deploy 11
Material Distortion 11
Mechanics altered 11
Device-device incompatibility 11
Foreign material present in device 11
Unintended movement 10
Packaging issue 10
Loss of or failure to bond 10
Device damaged prior to use 10
Device abrasion from instrument or another object 9
Device handling issue 9
Foreign material 8
Split 8
Cut in material 8
Output above specifications 8
Component(s), worn 7
Output issue 7
Malposition of device 7
Delamination 6
Blockage within device or device component 6
Product quality issue 6
Size incorrect for patient 5
Couple, failure to 5
Contamination during use 5
Flaked 5
Entrapment of device or device component 4
Total Device Problems 17734

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

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