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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 526
Break 168
Corrosion 79
Fracture 48
Material fragmentation 44
Device operates differently than expected 15
Fitting problem 14
No Known Device Problem 14
Malfunction 9
Unknown (for use when the device problem is not known) 9
Component missing 9
No code available 8
Mechanical jam 8
Device, or device fragments remain in patient 7
Difficult to remove 6
Detachment of device or device component 6
Material deformation 6
No Information 5
Other (for use when an appropriate device code cannot be identified) 5
Bent 5
Sticking 4
Detachment of device component 4
Device, removal of (non-implant) 4
Metal shedding debris 3
Device clogged 3
Failure to Adhere or Bond 2
Use of Device Issue 2
Improper or incorrect procedure or method 2
Failure to separate 2
Connection issue 2
Naturally worn 2
Material integrity issue 1
Device handling issue 1
Packaging issue 1
Unintended movement 1
Failure to auto stop 1
Inadequate user interface 1
Failure to cut 1
Device or device fragments location unknown 1
Malposition of device 1
Cut in material 1
Tip breakage 1
Device inoperable 1
Size incorrect for patient 1
Crack 1
Foreign material 1
Component(s), broken 1
Difficult to insert 1
Loose or intermittent connection 1
Mechanical issue 1
Monitor failure 1
Unintended collision 1
Total Device Problems 1042

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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