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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device suture, nonabsorbable, synthetic, polyamide
Regulation Description Nonabsorbable polyamide surgical suture.
Product CodeGAR
Regulation Number 878.5020
Device Class 2


Premarket Reviews
ManufacturerDecision
AESCULAP
  SUBSTANTIALLY EQUIVALENT 1
AESCULAP, INC.
  SUBSTANTIALLY EQUIVALENT 1
RIVERPOINT MEDICAL
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Break 828
Material Separation 211
Appropriate Term/Code Not Available 94
Detachment of Device or device Component 90
Adverse Event Without Identified Device or Use Problem 74
Detachment Of Device Component 63
Material Integrity Problem 42
Failure To Adhere Or Bond 40
Device Markings / Labelling Problem 25
Manufacturing, Packaging or Shipping Problem 20
Product Quality Problem 20
Patient-Device Incompatibility 18
Bent 17
Packaging Problem 15
Device Misassembled During Manufacturing / Shipping 15
Component Incompatible 12
Tear, Rip or Hole in Device Packaging 11
Inadequacy of Device Shape and/or Size 9
Unsealed Device Packaging 8
Material Frayed 7
Device Operates Differently Than Expected 7
Crack 5
Dull, Blunt 4
Material Twisted / Bent 4
Difficult to Open or Remove Packaging Material 4
Fracture 3
Material Split, Cut or Torn 3
Knotted 3
Component Misassembled 3
Device Contamination with Chemical or Other Material 2
Needle, separation 2
Material Too Rigid or Stiff 2
Unraveled Material 2
Misassembled 2
Material Discolored 2
Incomplete or Missing Packaging 2
Component Missing 2
Device Damaged Prior to Use 2
Defective Component 2
Material Fragmentation 1
Kinked 1
Poor Quality Image 1
Other (for use when an appropriate device code cannot be identified) 1
Thread 1
Incorrect Device Or Component Shipped 1
Difficult to Remove 1
Label 1
Tip 1
Inaccurate Information 1
Material Deformation 1
Occlusion Within Device 1
Material Rupture 1
Out-Of-Box Failure 1
Loss of or Failure to Bond 1
Needle 1
Mechanical Problem 1
Delivered as Unsterile Product 1
Device Disinfection Or Sterilization Issue 1
Total Device Problems 1694

Recalls
Manufacturer Recall Class Date Posted
1 Riverpoint Medical, LLC II Sep-08-2016

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