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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device tray, surgical, instrument
Regulation Description Manual surgical instrument for general use.
Product CodeFSM
Regulation Number 878.4800
Device Class 1

Device Problems
Break 125
Peeled / Delaminated 109
Delamination 98
Naturally Worn 27
Adverse Event Without Identified Device or Use Problem 27
Appropriate Term/Code Not Available 24
Material Twisted / Bent 24
Crack 18
Incorrect Measurement 12
Contamination / decontamination Problem 8
Corroded 6
Flaked 6
Material Fragmentation 6
Failure to Align 5
Manufacturing, Packaging or Shipping Problem 4
Device Operates Differently Than Expected 4
Device Contamination with Chemical or Other Material 4
Dull, Blunt 3
Loss of or Failure to Bond 3
Device Displays Incorrect Message 3
Scratched Material 3
Device Damaged Prior to Use 3
Detachment of Device or device Component 3
Loose or Intermittent Connection 3
Component Missing 3
Residue After Decontamination 3
Device Markings / Labelling Problem 2
Device-Device Incompatibility 2
Physical Property Issue 2
Defective Device 2
Mechanical Problem 2
Coagulation in Device or device Ingredient 2
Component Incompatible 2
Material Deformation 2
Material Erosion 1
Component or Accessory Incompatibility 1
Device Issue 1
Difficult to Advance 1
Material Integrity Problem 1
Tip 1
Bent 1
Migration or Expulsion of Device 1
Electromagnetic Interference 1
Failure To Adhere Or Bond 1
Device Reprocessing Problem 1
Delivered as Unsterile Product 1
Insufficient Information 1
Mechanical Jam 1
Packaging Problem 1
Material Separation 1
Inadequacy of Device Shape and/or Size 1
Metal Shedding Debris 1
Fitting Problem 1
Detachment Of Device Component 1
Defective Component 1
Difficult or Delayed Activation 1
Incorrect Or Inadequate Test Results 1
Device Packaging Compromised 1
Difficult to Open or Close 1
Incorrect Device Or Component Shipped 1
Difficult to Remove 1
Entrapment of Device 1
Fracture 1
Sharp Edges 1
Overheating of Device 1
Material Discolored 1
Connection Problem 1
Total Device Problems 583

Recalls
Manufacturer Recall Class Date Posted
1 Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables II Dec-22-2016
2 Stryker Craniomaxillofacial Division II Oct-08-2015
3 Synthes (USA) Products LLC II Jun-15-2018
4 Synthes (USA) Products LLC II Dec-21-2016
5 Synthes (USA) Products LLC II Aug-20-2015
6 Zimmer Biomet, Inc. II Jul-12-2019
7 Zimmer Biomet, Inc. II Jan-14-2019
8 Zimmer, Inc. II Oct-06-2015

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