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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 4507
No code available 821
Fracture 680
Dull 394
Material integrity issue 313
No Information 246
Corrosion 206
Malfunction 198
Device operates differently than expected 194
Tip breakage 175
Crack 174
Component missing 166
Detachment of device component 150
Device, or device fragments remain in patient 148
Bent 133
Mechanical jam 116
Other (for use when an appropriate device code cannot be identified) 104
Unknown (for use when the device problem is not known) 98
Device remains implanted 97
Failure to align 90
Fitting problem 87
Material fragmentation 85
Disassembly 77
Difficult to remove 77
No Known Device Problem 70
Mechanical issue 69
Sticking 68
Material deformation 63
Naturally worn 50
Device, removal of (non-implant) 49
Use of Device Issue 47
Loose or intermittent connection 46
Detachment of device or device component 44
Component(s), broken 43
Degraded 39
Not Applicable 39
Device inoperable 33
Material discolored 32
Implant, removal of 32
Device or device fragments location unknown 31
Slippage of device or device component 30
Difficult to insert 28
Failure to Adhere or Bond 26
Device Issue 22
Metal shedding debris 21
Dislodged or dislocated 19
Connection issue 17
Component falling 17
Material separation 16
Failure to separate 14
Disengaged 13
Defective item 13
Improper or incorrect procedure or method 13
Device Cleaning Issue 13
Incorrect measurement 12
Manufacturing or shipping issue associated with device 12
Positioning Issue 12
Mechanics altered 11
Failure to disconnect 11
Loose 11
Difficult to deploy 11
Migration of device or device component 10
Foreign material present in device 10
Peeled 9
Disconnection 9
Difficult to open or close 9
Foreign material 8
Failure to advance 7
Component(s), worn 7
Malposition of device 6
Difficult to position 6
Packaging issue 6
Split 6
Defective component 6
Product quality issue 5
Couple, failure to 5
Loss of or failure to bond 5
Material Distortion 5
Device markings issue 5
Device-device incompatibility 5
Size incorrect for patient 4
Accessory incompatible 4
Device or device component damaged by another device 4
Device damaged prior to use 4
Scratched material 4
Cut in material 4
Stretched 4
Device abrasion from instrument or another object 4
Intermittent continuity 4
Residue after decontamination 4
Contamination during use 4
Human-Device Interface Issue 4
Material twisted 4
Incompatibility problem 3
Locking mechanism failure 3
Unraveled material 3
Explanted 3
Structural problem 3
Overheating of device or device component 3
Inadequate user interface 3
Total Device Problems 10635

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 8 14 8 25 13 19 25 18 15 2
Class III 0 1 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 ArthroCare Medical Corporation II Jan-09-2014
4 Bacterin International, Inc. II Apr-07-2015
5 Biomet Microfixation, Inc. II Aug-01-2011
6 Biomet Microfixation, Inc. II Nov-10-2009
7 Biomet U.K., Ltd. II Mar-19-2012
8 Biomet, Inc. II Feb-25-2016
9 Biomet, Inc. II Jun-16-2014
10 Biomet, Inc. II Mar-20-2014
11 Biomet, Inc. II Jun-15-2013
12 Biomet, Inc. II Mar-08-2013
13 Biomet, Inc. II Sep-30-2011
14 Biomet, Inc. II Jun-30-2011
15 Biomet, Inc. II Dec-28-2010
16 Biomet, Inc. II Sep-28-2010
17 Biomet, Inc. II Sep-25-2010
18 Biomet, Inc. II Jan-15-2010
19 Biomet, Inc. II Jun-01-2009
20 Biomet, Inc. II Jan-07-2009
21 Biomet, Inc. II Oct-24-2008
22 Biomet, Inc. II Sep-11-2008
23 Biomet, Inc. II Aug-20-2008
24 Biomet, Inc. II Feb-05-2008
25 Biomet, Inc. II Jan-23-2008
26 Biomet, Inc. II Dec-22-2007
27 Biomet, Inc. II Aug-07-2007
28 Captiva Spine, Inc II Apr-21-2015
29 DePuy Mitek, Inc., a Johnson & Johnson Co. II Aug-31-2011
30 DePuy Orthopaedics, Inc. II Oct-07-2015
31 DePuy Orthopaedics, Inc. II Mar-31-2015
32 DePuy Orthopaedics, Inc. II Jan-12-2015
33 DePuy Orthopaedics, Inc. II Jan-05-2015
34 DePuy Orthopaedics, Inc. II Jan-05-2015
35 DePuy Orthopaedics, Inc. II Nov-10-2014
36 DePuy Orthopaedics, Inc. II Oct-08-2014
37 DePuy Orthopaedics, Inc. II Nov-27-2013
38 DePuy Orthopaedics, Inc. II Mar-19-2013
39 DePuy Orthopaedics, Inc. II Apr-16-2012
40 DePuy Orthopaedics, Inc. II Apr-16-2012
41 Depuy Orthopaedics, Inc. II Mar-22-2011
42 Depuy Orthopaedics, Inc. II Feb-22-2011
43 Depuy Orthopaedics, Inc. II Oct-06-2010
44 Ebi, Llc II Sep-17-2013
45 Encore Medical, Lp II Nov-02-2011
46 Encore Medical, Lp II Sep-30-2010
47 Encore Medical, Lp II Aug-02-2010
48 Greatbatch Medical II Jan-30-2013
49 Integra LifeSciences Corp. II Jan-23-2009
50 Kyphon Inc II Sep-18-2008
51 Linvatec Corp. dba ConMed Linvatec II Feb-05-2013
52 Linvatec Corp. dba ConMed Linvatec II Oct-29-2012
53 Linvatec Corp. dba ConMed Linvatec II Aug-06-2012
54 Linvatec Corp. dba ConMed Linvatec II Aug-06-2012
55 Linvatec Corp. dba ConMed Linvatec II Aug-24-2010
56 Medtronic Sofamor Danek USA Inc II Apr-19-2012
57 Medtronic Sofamor Danek USA Inc II Jan-12-2010
58 Medtronic Sofamor Danek USA Inc II Dec-22-2007
59 Microport Orthopedics INC. II Jun-04-2014
60 Orthohelix Surgical Designs Inc II Oct-10-2014
61 Orthohelix Surgical Designs Inc II Apr-15-2010
62 Smith & Nephew Inc II Jun-06-2012
63 Smith & Nephew Inc II Jun-24-2010
64 Smith & Nephew Inc II Aug-04-2009
65 Smith & Nephew Inc II Oct-25-2007
66 Smith & Nephew Inc II Jun-07-2007
67 Smith & Nephew, Inc. Endoscopy Division II Aug-22-2011
68 SpineFrontier, Inc. II Jan-14-2015
69 SpineFrontier, Inc. II Nov-14-2013
70 SpineFrontier, Inc. II Jul-05-2013
71 Stryker Craniomaxillofacial Division II Mar-23-2010
72 Stryker Howmedica Osteonics Corp. II Jul-02-2014
73 Stryker Howmedica Osteonics Corp. II Feb-10-2014
74 Stryker Howmedica Osteonics Corp. II Mar-18-2013
75 Stryker Howmedica Osteonics Corp. II Mar-08-2013
76 Stryker Howmedica Osteonics Corp. II Dec-22-2012
77 Stryker Howmedica Osteonics Corp. II Dec-04-2012
78 Stryker Howmedica Osteonics Corp. II Jul-26-2012
79 Stryker Howmedica Osteonics Corp. II May-17-2012
80 Stryker Howmedica Osteonics Corp. II Mar-22-2012
81 Stryker Howmedica Osteonics Corp. II Jan-18-2012
82 Stryker Howmedica Osteonics Corp. II Mar-16-2011
83 Stryker Howmedica Osteonics Corp. II Jan-19-2011
84 Stryker Howmedica Osteonics Corp. II Dec-27-2010
85 Stryker Howmedica Osteonics Corp. II Nov-26-2010
86 Stryker Howmedica Osteonics Corp. II Oct-13-2010
87 Stryker Howmedica Osteonics Corp. II Aug-02-2010
88 Stryker Howmedica Osteonics Corp. II Aug-02-2010
89 Stryker Howmedica Osteonics Corp. II Aug-02-2010
90 Stryker Howmedica Osteonics Corp. II May-10-2010
91 Stryker Howmedica Osteonics Corp. II Aug-26-2009
92 Stryker Howmedica Osteonics Corp. II Oct-28-2008
93 Stryker Howmedica Osteonics Corp. II Sep-20-2008
94 Stryker Howmedica Osteonics Corp. II Sep-16-2008
95 Stryker Howmedica Osteonics Corp. II Aug-17-2008
96 Stryker Howmedica Osteonics Corp. II Jul-26-2008
97 Stryker Leibinger USA II Feb-27-2007
98 Stryker Spine II Feb-19-2016
99 Stryker Spine II Nov-05-2015
100 Stryker Spine II Dec-16-2014
101 Stryker Spine II Sep-11-2014
102 Stryker Spine II Feb-25-2014
103 Stryker Spine II Nov-21-2013
104 Stryker Spine II Feb-28-2013
105 Stryker Spine II Nov-19-2012
106 Stryker Spine II Oct-29-2012
107 Stryker Spine II Jul-19-2012
108 Stryker Spine II Feb-15-2011
109 Stryker Spine II Jan-12-2011
110 Stryker Spine II Feb-16-2010
111 Stryker Spine II Aug-19-2008
112 Surgical Instrument Service And Savings, Inc. II Jul-01-2013
113 Synthes (USA) Products LLC II Oct-15-2015
114 Synthes (USA) Products LLC II Oct-05-2015
115 Synthes USA (HQ), Inc. II Jun-16-2010
116 Synthes USA HQ, Inc. II Nov-27-2013
117 Synthes USA HQ, Inc. II Nov-26-2013
118 Synthes USA HQ, Inc. II Nov-25-2013
119 Synthes USA HQ, Inc. II Nov-22-2013
120 Synthes USA HQ, Inc. II Nov-13-2013
121 Synthes USA HQ, Inc. II Sep-26-2013
122 Synthes USA HQ, Inc. II Jul-29-2013
123 Synthes USA HQ, Inc. II Apr-05-2013
124 Synthes, Inc. II Mar-10-2015
125 Synthes, Inc. II Jul-21-2014
126 Synthes, Inc. II Feb-20-2014
127 Synthes, Inc. II Feb-16-2014
128 Tedan Surgical Innovations Llc II Sep-14-2012
129 Wright Medical Technology Inc II Jun-07-2010
130 Wright Medical Technology Inc II Apr-28-2009
131 Wright Medical Technology Inc II Sep-17-2008
132 Zimmer Gmbh II Apr-27-2015
133 Zimmer Inc. II Jan-10-2011
134 Zimmer Inc. II Dec-13-2010
135 Zimmer Inc. II Oct-15-2010
136 Zimmer Inc. II Aug-26-2010
137 Zimmer Inc. II Feb-27-2009
138 Zimmer Inc. III Sep-17-2008
139 Zimmer Inc. II Sep-11-2008
140 Zimmer Inc. II Dec-15-2007
141 Zimmer Inc. II Mar-29-2007
142 Zimmer, Inc. II Dec-10-2015
143 Zimmer, Inc. II May-29-2015
144 Zimmer, Inc. II Aug-26-2014
145 Zimmer, Inc. II Aug-22-2014
146 Zimmer, Inc. II Aug-14-2014
147 Zimmer, Inc. II Aug-12-2013
148 Zimmer, Inc. II Jul-01-2013

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