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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 594
Break 186
Corrosion 79
Material fragmentation 51
Fracture 49
No code available 49
Device operates differently than expected 16
No Known Device Problem 14
Fitting problem 14
Component missing 10
Malfunction 9
Unknown (for use when the device problem is not known) 9
Mechanical jam 8
Detachment of device or device component 8
No Information 7
Device, or device fragments remain in patient 7
Difficult to remove 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
Metal shedding debris 3
Device clogged 3
Naturally worn 3
Connection issue 2
Failure to Adhere or Bond 2
Loose or intermittent connection 2
Improper or incorrect procedure or method 2
Failure to separate 2
Use of Device Issue 2
Cut in material 1
Failure to cut 1
Device or device fragments location unknown 1
Malposition of device 1
Tip breakage 1
Device inoperable 1
Size incorrect for patient 1
Mechanical issue 1
Monitor failure 1
Unintended collision 1
Difficult to position 1
Difficult to insert 1
Device Cleaning Issue 1
Component(s), broken 1
Crack 1
Foreign material 1
Failure to auto stop 1
Inadequate user interface 1
Material integrity issue 1
Packaging issue 1
Unintended movement 1
Device handling issue 1
Total Device Problems 1187

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 3
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 Jun-06-2016
13 Synthes (USA) Products LLC II Jan-05-2016
14 Synthes (USA) Products LLC II Aug-10-2015
15 Synthes USA HQ, Inc. II Aug-12-2013
16 Synthes, Inc. II Jul-16-2015
17 Trilliant Surgical Ltd. II Aug-24-2015

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