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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device saw, powered, and accessories
Regulation Description Surgical instrument motors and accessories/attachments.
Product CodeHAB
Regulation Number 878.4820
Device Class 1

Device Problems
Overheating of Device 368
Sparking 29
Metal Shedding Debris 24
Flaked 19
Material Separation 17
Smoking 13
Mechanical Problem 13
Insufficient Information 12
Electrical /Electronic Property Problem 12
Noise, Audible 11
Break 11
Unintended power up 10
Electrical Shorting 9
Device Operates Differently Than Expected 9
Melted 8
Fluid Leak 7
Device Remains Activated 6
Unintended Movement 6
Knife 6
Appropriate Term/Code Not Available 6
Device Inoperable 5
Connection Problem 5
Handpiece 5
Material Fragmentation 5
Self-Activation or Keying 5
Material Frayed 4
Adverse Event Without Identified Device or Use Problem 4
Temperature Problem 4
Activation, Positioning or Separation Problem 4
Device Contamination with Chemical or Other Material 3
Dull, Blunt 3
Mechanical Jam 3
Material Opacification 2
Corroded 2
Loose or Intermittent Connection 2
Failure to Shut Off 2
Thermal Decomposition of Device 2
Detachment of Device or device Component 2
Device Markings / Labelling Problem 1
Device Displays Incorrect Message 1
Physical Resistance / Sticking 1
Unclear Information 1
Component Missing 1
Separation Failure 1
Leak / Splash 1
Material Discolored 1
Device Operational Issue 1
Pin 1
Improper or Incorrect Procedure or Method 1
No Apparent Adverse Event 1
Fitting Problem 1
Detachment Of Device Component 1
Power Problem 1
Partial Blockage 1
Intermittent loss of power 1
Shaft 1
Loss of Power 1
Vibration 1
Device Issue 1
Tip 1
Image Display Error / Artifact 1
Cut In Material 1
Material Twisted / Bent 1
Total Device Problems 683

Recalls
Manufacturer Recall Class Date Posted
1 Arthrex, Inc. II Oct-30-2018
2 Smith & Nephew, Inc. II Feb-22-2017
3 Zimmer Biomet, Inc. II Oct-26-2016
4 Zimmer, Inc. II Dec-21-2015

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