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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device instrument, surgical, orthopedic, ac-powered motor and accessory/attachment
Regulation Description Surgical instrument motors and accessories/attachments.
Product CodeHWE
Regulation Number 878.4820
Device Class 1


Premarket Reviews
ManufacturerDecision
3M COMPANY
  SUBSTANTIALLY EQUIVALENT 2
AESCULAP
  SUBSTANTIALLY EQUIVALENT 2
ARTHREX, INC.
  SUBSTANTIALLY EQUIVALENT 1
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 1
CHATTANOOGA GROUP
  SUBSTANTIALLY EQUIVALENT 1
CODMAN & SHURTLEFF, INC.
  SUBSTANTIALLY EQUIVALENT 1
EXACTECH, INC.
  SUBSTANTIALLY EQUIVALENT 1
KARL STORZ GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1
LINVATEC
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE
  SUBSTANTIALLY EQUIVALENT 1
MICROAIRE
  SUBSTANTIALLY EQUIVALENT 1
RICHARD WOLF
  SUBSTANTIALLY EQUIVALENT 3
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 4
SYNTHES
  SUBSTANTIALLY EQUIVALENT 3
THE ANSPACH EFFORT, INC.
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
Unintended system motion 801
Fail-safe mechanism issue 734
Device inoperable 660
Break 338
Noise, Audible 332
Mechanical jam 312
Device operates differently than expected 296
Overheating of device or device component 258
Mechanical issue 213
Unintended energization 169
Fracture 144
Device remains activated 130
Disassembly 124
Battery issue 110
Metal shedding debris 94
Material fragmentation 90
Sticking 84
Leak 78
Failure to power-up 69
No code available 57
Detachment of device component 51
Vibration 50
Migration of device or device component 47
Component missing 44
Failure to charge 42
Loose or intermittent connection 41
Device disinfection or sterilization issue 40
Device stops intermittently 39
Blockage within device or device component 32
Output below specifications 32
Temperature issue 32
Difficult to position 31
Loss of power 27
Naturally worn 27
Slippage of device or device component 25
Self-activation or keying 24
Biocompatibility issue 23
Defective item 22
Positioning Issue 20
Smoking 20
Defective component 18
Power source issue 17
Failure to shut off 16
Fluid leak 14
Detachment of device or device component 13
Connection issue 13
Material separation 12
Difficult to remove 12
Difficult to insert 11
Charging issue 11
Fitting problem 11
Dull 11
No Information 10
Air leak 10
Premature discharge of battery 10
Bent 10
Power Conditioning Issue 10
No device output 9
Melted 8
Material integrity issue 8
Physical resistance 7
Spark 7
Device displays error message 6
Other (for use when an appropriate device code cannot be identified) 6
Foreign material present in device 6
Material deformation 6
Burn of device or device component 6
Crack 6
Disconnection 6
Improper or incorrect procedure or method 5
Unintended movement 5
No Known Device Problem 5
No fail-safe mechanism 4
Failure to align 4
Application interface becomes non-functional or program exits abnormally 4
Degraded 4
Corrosion 4
Size incorrect for patient 3
Failure to disconnect 3
Disinfection or Sterilization Issue at User Location 3
Mechanics altered 3
Difficult to open or close 3
Inadequate user interface 3
Scratched material 3
Device handling issue 3
No Pressure 2
Operating system becomes non-functional 2
Failure of device to self-test 2
Difficult or delayed activation 2
Cut in material 2
Device contamination with blood or blood product 2
Retraction problem 2
Unstable 2
Misconnection 2
Moisture damage 2
Delivered as unsterile product 2
Device emits odor 2
Continuous firing 2
Loss of or failure to bond 2
Circuit Failure 2
Total Device Problems 6141

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 1 0 0 0 0 0 0 1 0
Class II 0 0 3 1 3 0 1 1 6 4 1
Class III 0 0 0 0 0 0 0 0 1 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Biomet, Inc. II Sep-08-2009
2 EXP Pharmaceutical Services Corp II Jul-24-2015
3 Greatbatch Medical II Jun-01-2016
4 Linvatec Corp. dba ConMed Linvatec II Apr-04-2011
5 Linvatec Corp. dba ConMed Linvatec I Oct-01-2009
6 Medtronic Sofamor Danek USA Inc II Jan-12-2015
7 Smith & Nephew, Inc., Endoscopy Div. II Oct-22-2015
8 Stryker Instruments Div. of Stryker Corporation II Apr-27-2017
9 Stryker Instruments Div. of Stryker Corporation II Oct-18-2016
10 Stryker Instruments Div. of Stryker Corporation III May-07-2015
11 Stryker Instruments Div. of Stryker Corporation II Feb-09-2015
12 Stryker Instruments Div. of Stryker Corporation II Nov-05-2014
13 Stryker Instruments Div. of Stryker Corporation II Sep-13-2010
14 Stryker Instruments Div. of Stryker Corporation II Mar-30-2009
15 Synthes (USA) Products LLC II Dec-01-2016
16 Synthes (USA) Products LLC II Jul-12-2016
17 Synthes USA (HQ), Inc. II Dec-02-2011
18 Synthes USA (HQ), Inc. II Oct-26-2009
19 Synthes USA HQ, Inc. II Dec-31-2013
20 Synthes, Inc. II Mar-23-2015
21 The Anspach Effort, Inc. I Sep-27-2016
22 The Anspach Effort, Inc. II Apr-30-2015
23 W & H DentalWerk Buermoos GMBH II Jul-25-2011

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