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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
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 1465
Fracture 347
Malfunction 196
Tip breakage 167
Device, or device fragments remain in patient 146
No Information 115
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
No code available 65
Device, removal of (non-implant) 49
Disassembly 43
Component(s), broken 42
Fitting problem 35
Implant, removal of 32
Component missing 25
Loose or intermittent connection 22
Detachment of device component 21
Use of Device Issue 20
Not Applicable 18
Difficult to insert 17
Device or device fragments location unknown 16
Device Issue 16
Bent 15
Device inoperable 14
Crack 14
Failure to align 13
Disengaged 13
Loose 11
Difficult to remove 11
Naturally worn 8
Mechanical issue 8
Foreign material 8
Incorrect measurement 8
Metal shedding debris 8
Difficult to deploy 8
Connection issue 7
Slippage of device or device component 7
No Known Device Problem 7
Material fragmentation 7
Component(s), worn 7
Difficult to open or close 6
Device Cleaning Issue 6
Failure to Adhere or Bond 6
Loss of or failure to bond 5
Couple, failure to 5
Detachment of device or device component 5
Failure to separate 5
Sticking 4
Intermittent continuity 4
Dislodged or dislocated 4
Defective item 3
Explanted 3
Structural problem 3
Contamination during use 3
Cut in material 3
Packaging issue 3
Failure to deploy 3
Normal 3
Device abrasion from instrument or another object 3
Accessory incompatible 3
Locking mechanism failure 3
Device markings issue 2
Blocked connection 2
Device damaged prior to use 2
Peeled 2
Dull 2
Difficult to position 2
Implant extrusion 2
Defective component 2
Failure to disconnect 2
Design/structure problem 2
Insulation, detached 2
Flaked 2
Twisting 2
Residue after decontamination 2
Disconnection 2
Invalid sensing 2
Component falling 2
Unintended movement 1
Loss of osseointegration 1
Blockage within device or device component 1
Burn of device or device component 1
Size incorrect for patient 1
Head immobilizer failure 1
Mechanical jam 1
Repair 1
Motor failure 1
Measurements, inaccurate 1
Component incompatible 1
Misassembled 1
Unsealed device packaging 1
Incompatibility problem 1
Failure to auto stop 1
Device or device component damaged by another device 1
Migration of device or device component 1
Implant breakage or physical damage 1
Needle, separation 1
Cannula Guide Issue, No Description 1
Failure to flush 1
Total Device Problems 3468

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 0 0 0
Class II 8 15 8 25 13 19 8
Class III 0 1 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Aesculap, Inc. II Oct-18-2012
2 Biomet Microfixation, Inc. II Aug-01-2011
3 Biomet Microfixation, Inc. II Nov-10-2009
4 Biomet U.K., Ltd. II Mar-19-2012
5 Biomet, Inc. II Mar-08-2013
6 Biomet, Inc. II Sep-30-2011
7 Biomet, Inc. II Jun-30-2011
8 Biomet, Inc. II Dec-28-2010
9 Biomet, Inc. II Sep-28-2010
10 Biomet, Inc. II Sep-25-2010
11 Biomet, Inc. II Jan-15-2010
12 Biomet, Inc. II Jun-01-2009
13 Biomet, Inc. II Jan-07-2009
14 Biomet, Inc. II Oct-24-2008
15 Biomet, Inc. II Sep-11-2008
16 Biomet, Inc. II Aug-20-2008
17 Biomet, Inc. II Feb-05-2008
18 Biomet, Inc. II Jan-23-2008
19 Biomet, Inc. II Dec-22-2007
20 Biomet, Inc. II Aug-07-2007
21 DePuy Mitek, Inc., a Johnson & Johnson Co. II Aug-31-2011
22 DePuy Orthopaedics, Inc. II Mar-19-2013
23 DePuy Orthopaedics, Inc. II Apr-16-2012
24 DePuy Orthopaedics, Inc. II Apr-16-2012
25 Depuy Orthopaedics, Inc. II Mar-22-2011
26 Depuy Orthopaedics, Inc. II Feb-22-2011
27 Depuy Orthopaedics, Inc. II Oct-06-2010
28 Encore Medical, Lp II Nov-02-2011
29 Encore Medical, Lp II Sep-30-2010
30 Encore Medical, Lp II Aug-02-2010
31 Greatbatch Medical II Jan-30-2013
32 Integra LifeSciences Corp. II Jan-23-2009
33 Kyphon Inc II Sep-18-2008
34 Linvatec Corp. dba ConMed Linvatec II Feb-05-2013
35 Linvatec Corp. dba ConMed Linvatec II Oct-29-2012
36 Linvatec Corp. dba ConMed Linvatec II Aug-06-2012
37 Linvatec Corp. dba ConMed Linvatec II Aug-06-2012
38 Linvatec Corp. dba ConMed Linvatec II Aug-24-2010
39 Medline Industries Inc II Oct-10-2008
40 Medtronic Sofamor Danek USA Inc II Apr-19-2012
41 Medtronic Sofamor Danek USA Inc II Jan-12-2010
42 Medtronic Sofamor Danek USA Inc II Dec-22-2007
43 Orthohelix Surgical Designs Inc II Apr-15-2010
44 Smith & Nephew Inc II Jun-06-2012
45 Smith & Nephew Inc II Jun-24-2010
46 Smith & Nephew Inc II Aug-04-2009
47 Smith & Nephew Inc II Oct-25-2007
48 Smith & Nephew Inc II Jun-07-2007
49 Smith & Nephew, Inc. Endoscopy Division II Aug-22-2011
50 Stryker Craniomaxillofacial Division II Mar-23-2010
51 Stryker Howmedica Osteonics Corp. II Mar-18-2013
52 Stryker Howmedica Osteonics Corp. II Mar-08-2013
53 Stryker Howmedica Osteonics Corp. II Dec-22-2012
54 Stryker Howmedica Osteonics Corp. II Dec-04-2012
55 Stryker Howmedica Osteonics Corp. II Jul-26-2012
56 Stryker Howmedica Osteonics Corp. II May-17-2012
57 Stryker Howmedica Osteonics Corp. II Mar-22-2012
58 Stryker Howmedica Osteonics Corp. II Jan-18-2012
59 Stryker Howmedica Osteonics Corp. II Mar-16-2011
60 Stryker Howmedica Osteonics Corp. II Jan-19-2011
61 Stryker Howmedica Osteonics Corp. II Dec-27-2010
62 Stryker Howmedica Osteonics Corp. II Nov-26-2010
63 Stryker Howmedica Osteonics Corp. II Oct-13-2010
64 Stryker Howmedica Osteonics Corp. II Aug-02-2010
65 Stryker Howmedica Osteonics Corp. II Aug-02-2010
66 Stryker Howmedica Osteonics Corp. II Aug-02-2010
67 Stryker Howmedica Osteonics Corp. II May-10-2010
68 Stryker Howmedica Osteonics Corp. II Aug-26-2009
69 Stryker Howmedica Osteonics Corp. II Oct-28-2008
70 Stryker Howmedica Osteonics Corp. II Sep-20-2008
71 Stryker Howmedica Osteonics Corp. II Sep-16-2008
72 Stryker Howmedica Osteonics Corp. II Aug-17-2008
73 Stryker Howmedica Osteonics Corp. II Jul-26-2008
74 Stryker Leibinger USA II Feb-27-2007
75 Stryker Spine II Feb-28-2013
76 Stryker Spine II Nov-19-2012
77 Stryker Spine II Oct-29-2012
78 Stryker Spine II Jul-19-2012
79 Stryker Spine II Feb-15-2011
80 Stryker Spine II Jan-12-2011
81 Stryker Spine II Feb-16-2010
82 Stryker Spine II Aug-19-2008
83 Synthes USA (HQ), Inc. II Jun-16-2010
84 Synthes USA HQ, Inc. II Apr-05-2013
85 Tedan Surgical Innovations Llc II Sep-14-2012
86 Wright Medical Technology Inc II Jun-07-2010
87 Wright Medical Technology Inc II Apr-28-2009
88 Wright Medical Technology Inc II Sep-17-2008
89 Zimmer Inc. II Jan-10-2011
90 Zimmer Inc. II Dec-13-2010
91 Zimmer Inc. II Oct-15-2010
92 Zimmer Inc. II Aug-26-2010
93 Zimmer Inc. II Feb-27-2009
94 Zimmer Inc. III Sep-17-2008
95 Zimmer Inc. II Sep-11-2008
96 Zimmer Inc. II Dec-15-2007
97 Zimmer Inc. II Mar-29-2007

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