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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device gauge, depth
Regulation Description Depth gauge for clinical use.
Product CodeHTJ
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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