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TPLC - Total Product Life Cycle
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TPLC
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Show TPLC since
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Device
gauge, depth
Regulation Description
Depth gauge for clinical use.
Product Code
HTJ
Regulation Number
888.4300
Device Class
1
Device Problems
Break
383
Material Fragmentation
45
Component Missing
36
Incorrect Measurement
29
Mechanical Jam
29
Device Operates Differently Than Expected
27
Bent
19
Sticking
15
Fracture
15
Fitting Problem
7
Detachment of Device or device Component
6
Appropriate Term/Code Not Available
5
Naturally Worn
4
Device Reprocessing Problem
4
Material Twisted / Bent
4
Misassembled
3
Insufficient Information
3
Device Markings / Labelling Problem
3
Device-Device Incompatibility
3
Failure to Align
3
Difficult to Remove
3
Particulates
3
Calibration Problem
2
Difficult To Position
2
Output Problem
2
Display Difficult to Read
2
Mechanical Problem
2
Material Separation
2
Material Deformation
2
Patient Device Interaction Problem
1
Device Fell
1
Material Too Rigid or Stiff
1
Component Falling
1
Disassembly
1
Detachment Of Device Component
1
Metal Shedding Debris
1
Dull, Blunt
1
Device Damaged by Another Device
1
Packaging Problem
1
Positioning Problem
1
Physical Resistance / Sticking
1
Adverse Event Without Identified Device or Use Problem
1
Separation Failure
1
No Apparent Adverse Event
1
Device Contamination with Body Fluid
1
Gauges/Meters
1
Material Discolored
1
Total Device Problems
681
Recalls
Manufacturer
Recall Class
Date Posted
1
Zimmer Biomet, Inc.
II
Jul-04-2019
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