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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device reamer
Regulation Description Orthopedic manual surgical instrument.
Product CodeHTO
Regulation Number 888.4540
Device Class 1


Premarket Reviews
ManufacturerDecision
3M COMPANY
  SUBSTANTIALLY EQUIVALENT 1
DEPUY INTL., LTD.
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
ONYX MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 1
SYNTHES
  SUBSTANTIALLY EQUIVALENT 3
THE ANSPACH EFFORT, INC.
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Dull 683
Break 243
Corrosion 191
No code available 132
Material fragmentation 60
Fracture 55
Device operates differently than expected 19
Fitting problem 16
Component missing 14
No Known Device Problem 14
Mechanical jam 11
Detachment of device or device component 11
Malfunction 9
Unknown (for use when the device problem is not known) 9
No Information 8
Device, or device fragments remain in patient 7
Difficult to remove 6
Metal shedding debris 6
Material deformation 6
Other (for use when an appropriate device code cannot be identified) 5
Bent 5
Detachment of device component 4
Sticking 4
Device, removal of (non-implant) 4
Connection issue 3
Naturally worn 3
Device clogged 3
Crack 3
Failure to Adhere or Bond 2
Loose or intermittent connection 2
Improper or incorrect procedure or method 2
Use of Device Issue 2
Packaging issue 2
Foreign material present in device 2
Failure to separate 2
Failure to cut 1
Device or device fragments location unknown 1
Malposition of device 1
Difficult to advance 1
Failure to auto stop 1
Inadequate user interface 1
Material integrity issue 1
Material twisted 1
Unintended movement 1
Device handling issue 1
Cut in material 1
Tip breakage 1
Device inoperable 1
Difficult to insert 1
Material separation 1
Size incorrect for patient 1
Mechanical issue 1
Monitor failure 1
Unintended collision 1
Unsealed device packaging 1
Difficult to position 1
Component(s), broken 1
Device Cleaning Issue 1
Disassembly 1
Foreign material 1
Total Device Problems 1573

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 0 1 1 1 1 4 2 1 3 5
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Biomet, Inc. II May-26-2016
2 Biomet, Inc. II Oct-06-2014
3 Biomet, Inc. II Dec-04-2012
4 Biomet, Inc. II Mar-04-2011
5 DePuy Mitek, Inc., a Johnson & Johnson Co. II Dec-17-2012
6 DePuy Orthopaedics, Inc. II Mar-20-2013
7 Extremity Medical LLC II Nov-26-2012
8 Sterilmed Inc II Jan-13-2009
9 Stryker Howmedica Osteonics Corp. II May-17-2012
10 Stryker Howmedica Osteonics Corp. II Feb-17-2010
11 Stryker Howmedica Osteonics Corp. II Aug-27-2008
12 Synthes (USA) Products LLC II Nov-23-2016
13 Synthes (USA) Products LLC II Nov-19-2016
14 Synthes (USA) Products LLC II Jun-06-2016
15 Synthes (USA) Products LLC II Jan-05-2016
16 Synthes (USA) Products LLC II Aug-10-2015
17 Synthes USA HQ, Inc. II Aug-12-2013
18 Synthes, Inc. II Jul-16-2015
19 Trilliant Surgical Ltd. II Aug-24-2015

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