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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device screw, fixation, bone
Regulation Description Smooth or threaded metallic bone fixation fastener.
Product CodeHWC
Regulation Number 888.3040
Device Class 2


Premarket Reviews
ManufacturerDecision
ACCUMED SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 5
  6
ADVANCED ORTHOPAEDIC SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 1
AESCULAP
  2
  SUBSTANTIALLY EQUIVALENT 2
ALPHATEC
  SUBSTANTIALLY EQUIVALENT 4
AMERICAN MEDICAL
  SUBSTANTIALLY EQUIVALENT 7
ARC SURGICAL LLC.
  SUBSTANTIALLY EQUIVALENT 3
ARTHREX, INC.
  1
  SUBSTANTIALLY EQUIVALENT 30
ARTHROCARE CORP.
  SUBSTANTIALLY EQUIVALENT 6
ARTHROTEK, INC.
  SUBSTANTIALLY EQUIVALENT 4
ASCENSION ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
BIOCOMPOSITES LTD.
  SUBSTANTIALLY EQUIVALENT 11
BIOMET
  4
  SUBSTANTIALLY EQUIVALENT 33
BIONX
  SUBSTANTIALLY EQUIVALENT 10
BIOPRO, INC.
  SUBSTANTIALLY EQUIVALENT 3
CAYENNE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 6
COAPT SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 10
CONMED
  SUBSTANTIALLY EQUIVALENT 5
DEPUY INTL., LTD.
  4
  SUBSTANTIALLY EQUIVALENT 27
DJ ORTHOPEDICS
  SUBSTANTIALLY EQUIVALENT 2
DOW
  SUBSTANTIALLY EQUIVALENT 2
EBI, L.P.
  SUBSTANTIALLY EQUIVALENT 1
ENCORE MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
EXACTECH, INC.
  SUBSTANTIALLY EQUIVALENT 1
FOURNITURES HOSPITALIERES INDUSTRIE
  SUBSTANTIALLY EQUIVALENT 5
GLOBUS
  SUBSTANTIALLY EQUIVALENT 1
HAYES
  1
IMPLEX
  SUBSTANTIALLY EQUIVALENT 1
INION
  SUBSTANTIALLY EQUIVALENT 11
KARL STORZ GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 4
KINETIKOS MEDICAL
  2
  SUBSTANTIALLY EQUIVALENT 5
KLS MARTIN GMBH + CO. KG
  SUBSTANTIALLY EQUIVALENT 1
LIFE SPINE
  SUBSTANTIALLY EQUIVALENT 2
LINVATEC
  3
  SUBSTANTIALLY EQUIVALENT 18
MEDLINE
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 2
MILLENNIUM
  SUBSTANTIALLY EQUIVALENT 2
MITEK
  SUBSTANTIALLY EQUIVALENT 9
MUSCULOSKELETAL TRANSPLANT FOUNDATION
  SUBSTANTIALLY EQUIVALENT 1
NEWDEAL
  SUBSTANTIALLY EQUIVALENT 9
NEXA ORTHOPEDICS
  SUBSTANTIALLY EQUIVALENT 3
ONYX MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 1
  10
OPUSMED INC.
  SUBSTANTIALLY EQUIVALENT 1
ORTHOHELIX SURGICAL DESIGN
  SUBSTANTIALLY EQUIVALENT 3
ORTHOPAEDIC BIOSYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
ORTHOPEDIC DESIGNS
  1
  SUBSTANTIALLY EQUIVALENT 1
ORTHOPEDIC SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 4
OSTEOMED
  SUBSTANTIALLY EQUIVALENT 13
OSTEOTECH, INC.
  1
PARCUS MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 5
PIONEER
  1
  SUBSTANTIALLY EQUIVALENT 4
PLUS ORTHOPEDICS
  SUBSTANTIALLY EQUIVALENT 1
REGENERATION TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 4
SCANDIUS BIOMEDICAL
  SUBSTANTIALLY EQUIVALENT 2
SMALL BONE INNOVATIONS
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 28
SPINAL CONCEPTS
  1
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 15
SULZER
  SUBSTANTIALLY EQUIVALENT 1
SYNTHES
  5
  SUBSTANTIALLY EQUIVALENT 26
T.A.G. MEDICAL PRODUCTS
  SUBSTANTIALLY EQUIVALENT 2
THE ANSPACH EFFORT, INC.
  SUBSTANTIALLY EQUIVALENT 1
THEKEN SPINE
  SUBSTANTIALLY EQUIVALENT 1
TORNIER
  SUBSTANTIALLY EQUIVALENT 2
TREU-INSTRUMENTE GMBH
  SUBSTANTIALLY EQUIVALENT 1
TRIAGE MEDICAL INC
  SUBSTANTIALLY EQUIVALENT 5
U&I CORP.
  SUBSTANTIALLY EQUIVALENT 1
UNITED STATES SURGICAL
  SUBSTANTIALLY EQUIVALENT 3
W. LORENZ SURGICAL
  SUBSTANTIALLY EQUIVALENT 4
W.L. GORE & ASSOCIATES,INC
  SUBSTANTIALLY EQUIVALENT 1
WRIGHT MEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 24
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 12

Device Problems
No Known Device Problem 1305
Break 1067
Unknown (for use when the device problem is not known) 440
No Information 253
Fracture 244
Implant, removal of 233
Migration of device or device component 222
Material fragmentation 200
Unintended movement 119
No code available 109
Loss of osseointegration 75
Device operates differently than expected 62
Device Issue 52
Electro-magnetic interference (EMI) 52
Device, or device fragments remain in patient 47
Fitting problem 46
Loose or intermittent connection 45
Device remains implanted 43
Difficult to remove 42
Difficult to insert 42
Use of Device Issue 40
Other (for use when an appropriate device code cannot be identified) 38
Component(s), broken 37
Loose 35
Improper or incorrect procedure or method 33
Malposition of device 33
Dislodged or dislocated 31
Detachment of device component 30
Malfunction 26
Corrosion 25
Failure to align 24
Displacement 22
Explanted 22
Material deformation 21
Implant breakage or physical damage 20
Detachment of device or device component 20
Bent 20
Component incompatible 17
Slippage of device or device component 16
Metal shedding debris 14
Failure to Adhere or Bond 14
Not Applicable 13
Device markings issue 10
Dull 10
Disengaged 10
Mechanical issue 10
Material frayed 9
Disassembly 9
Component missing 9
Implant, repositioning of 9
Deployment issue 9
Mechanical jam 9
Material integrity issue 8
Peeled 8
Material separation 7
Sticking 7
Tip breakage 6
Naturally worn 6
Component or accessory incompatibility 6
Extrusion 5
Foreign material present in device 5
Failure to separate 5
Defective item 5
Positioning Issue 5
Size incorrect for patient 5
Device expiration issue 5
Failure to deploy 5
Device inoperable 4
Failure to osseointegrate 4
Suture line separation 4
Material Protrusion 4
Material Distortion 4
Noise, Audible 4
Failure to disconnect 4
Patient-device incompatibility 4
Device packaging compromised 3
Tear, rip or hole in device packaging 3
Packaging issue 3
Mechanics altered 3
Unraveled material 3
Crack 3
Material disintegration 3
Loss of or failure to bond 3
Material discolored 3
Foreign material 3
Entrapment of device or device component 2
Unintended ejection 2
Dislocated 2
Degraded 2
Device damaged prior to use 2
Unexpected therapeutic results 2
Shelf life exceeded 2
Pitted 2
Difficult to position 2
Mislabeled 2
Unsealed device packaging 2
Material twisted 2
Manufacturing or shipping issue associated with device 2
Incompatibility problem 2
Device-device incompatibility 2
Total Device Problems 5523

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 0 6 3 10 4 10 12 11 13 12 2
Class III 0 1 1 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Acumed LLC II May-14-2010
2 Acumed LLC II Oct-23-2009
3 Acumed LLC II Sep-20-2008
4 Acumed LLC III Sep-11-2008
5 Acumed LLC II Aug-28-2008
6 ArthroCare Corporation II Oct-14-2011
7 Biomet Microfixation, Inc. II Jul-22-2011
8 Biomet Microfixation, Inc. II Jan-04-2010
9 Biomet, Inc. II May-26-2016
10 Biomet, Inc. II Jul-01-2015
11 Biomet, Inc. II Jan-30-2013
12 Biomet, Inc. II Mar-21-2012
13 Biomet, Inc. II Mar-09-2011
14 Biomet, Inc. II Feb-02-2010
15 Biomet, Inc. II Jan-13-2010
16 Biomet, Inc. II Nov-12-2009
17 DePuy Mitek, Inc., a Johnson & Johnson Co. II Oct-25-2012
18 Ebi, Llc II Nov-19-2013
19 Encore Medical, Lp II Oct-25-2012
20 Encore Medical, Lp II Aug-06-2012
21 Extremity Medical LLC II Jan-30-2013
22 Extremity Medical LLC II Nov-18-2012
23 Flower Orthopedics Corporation II Mar-24-2015
24 In2Bones, SAS II Dec-09-2015
25 In2Bones, SAS II Mar-25-2015
26 Innovatech Medical Resources L.P. II Jan-11-2012
27 Instratek, Incorporated II Sep-22-2014
28 Integra LifeSciences Corp. II Aug-19-2016
29 Integra LifeSciences Corp. II Aug-15-2008
30 Integra LifeSciences Corporation II Jun-02-2014
31 Integra LifeSciences Corporation II Apr-07-2010
32 Medartis, Inc. II Oct-30-2014
33 MicroAire Surgical Instruments, LLC II Jul-27-2016
34 Ortho Solutions Inc II Sep-16-2016
35 Ortho Solutions Inc II Oct-06-2015
36 OrthoPediatrics Corp II Sep-19-2016
37 OrthoPediatrics Corp II Feb-06-2014
38 OrthoPediatrics Corp II Aug-09-2013
39 OrthoPediatrics Corp II Jun-12-2013
40 Orthohelix Surgical Designs Inc II Oct-09-2012
41 Orthohelix Surgical Designs Inc II Jun-10-2010
42 Orthohelix Surgical Designs Inc II Apr-06-2010
43 Orthopedic Alliance LLC II May-24-2013
44 Pega Medical Inc. II Nov-20-2015
45 Pega Medical Inc. II Jun-26-2015
46 Small Bone Innovations II Jul-30-2014
47 Smith & Nephew, Inc. Endoscopy Division II Sep-17-2013
48 Smith & Nephew, Inc. Endoscopy Division II Mar-19-2012
49 Smith & Nephew, Inc. Endoscopy Division II Mar-19-2008
50 Stryker Craniomaxillofacial Division II May-07-2010
51 Stryker Endoscopy II Dec-14-2010
52 Stryker Endoscopy II Aug-06-2008
53 Stryker Howmedica Osteonics Corp. II Apr-18-2016
54 Stryker Howmedica Osteonics Corp. II Dec-11-2013
55 Stryker Howmedica Osteonics Corp. II Aug-27-2013
56 Stryker Howmedica Osteonics Corp. II Nov-19-2012
57 Stryker Howmedica Osteonics Corp. III Sep-14-2009
58 Stryker Howmedica Osteonics Corp. II Sep-22-2008
59 Synthes (USA) Products LLC II Jul-11-2016
60 Synthes (USA) Products LLC II Apr-27-2016
61 Synthes (USA) Products LLC II Nov-20-2015
62 Synthes (USA) Products LLC II Sep-18-2015
63 Synthes USA HQ, Inc. II Nov-26-2013
64 Synthes USA HQ, Inc. II Oct-17-2013
65 Synthes USA HQ, Inc. II Mar-28-2013
66 Synthes, Inc. II Jun-15-2015
67 Synthes, Inc. II Aug-19-2014
68 Synthes, Inc. II Jul-02-2014
69 Trilliant Surgical LTD II Apr-26-2010
70 Trilliant Surgical Ltd. II Jan-06-2017
71 Trilliant Surgical Ltd. II Nov-17-2016
72 Trilliant Surgical Ltd. II Aug-26-2015
73 Trilliant Surgical Ltd. II Aug-19-2015
74 Wright Medical Technology Inc II Jun-17-2011
75 Wright Medical Technology, Inc. II May-18-2015
76 Zimmer Biomet, Inc. II Feb-16-2017
77 Zimmer Biomet, Inc. II Jan-13-2016
78 Zimmer Inc. II Jan-26-2009
79 Zimmer Manufacturing B.V. II May-16-2016
80 Zimmer Manufacturing B.V. II Mar-12-2016
81 Zimmer Manufacturing B.V. II Jul-10-2014
82 Zimmer, Inc. II Aug-26-2014
83 Zimmer, Inc. II Aug-16-2014
84 Zimmer, Inc. II Feb-20-2014
85 Zimmer, Inc. II Nov-06-2012

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