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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device impactor
Regulation Description Orthopedic manual surgical instrument.
Product CodeHWA
Regulation Number 888.4540
Device Class 1

Device Problems
Break 4116
Crack 452
Fracture 356
Appropriate Term/Code Not Available 158
Device-Device Incompatibility 117
Naturally Worn 107
Material Deformation 98
Material Twisted / Bent 77
Scratched Material 69
Component Missing 42
Loose or Intermittent Connection 40
Connection Problem 38
Insufficient Information 35
Mechanical Jam 33
Disassembly 27
Detachment of Device or device Component 25
Material Fragmentation 24
Device Contamination with Chemical or Other Material 22
Contamination / decontamination Problem 18
Failure to Disconnect 17
Device Operates Differently Than Expected 16
Mechanical Problem 16
Difficult to Remove 16
Physical Resistance / Sticking 15
Adverse Event Without Identified Device or Use Problem 14
Dull, Blunt 14
Bent 13
Fitting Problem 11
Unintended Movement 10
Detachment Of Device Component 9
Sticking 7
Entrapment of Device 7
Corroded 6
Device Damaged by Another Device 6
Device Reprocessing Problem 6
Device Issue 5
Device Dislodged or Dislocated 4
Positioning Problem 4
Degraded 4
Material Discolored 4
Device Damaged Prior to Use 4
Defective Component 3
Separation Problem 3
No Apparent Adverse Event 3
Material Split, Cut or Torn 3
Problem with Sterilization 3
Separation Failure 3
Delivered as Unsterile Product 3
Defective Device 3
Use of Device Problem 3
Tip 3
Failure to Clean Adequately 2
Material Integrity Problem 2
Component Falling 2
Device Or Device Fragments Location Unknown 2
Material Rupture 2
Failure To Adhere Or Bond 2
Material Distortion 2
Device Difficult to Maintain 2
Flaked 2
Device Operational Issue 2
Device Difficult to Setup or Prepare 2
Device Slipped 2
Difficult to Insert 2
Burst Container or Vessel 1
Disconnection 1
Structural Problem 1
Failure to Align 1
Delamination 1
Missing Information 1
Explosion 1
Particulates 1
Imprecision 1
Material Protrusion / Extrusion 1
Device Inoperable 1
Misconnection 1
Device Disinfection Or Sterilization Issue 1
Locking Mechanism 1
Loss of Osseointegration 1
Dent in Material 1
Screw 1
Fluid Leak 1
Circuit Breaker 1
Device Fell 1
Failure to Discharge 1
Material Disintegration 1
Retraction Problem 1
Blocked Connection 1
Compatibility Problem 1
Migration or Expulsion of Device 1
Peeled / Delaminated 1
Pitted 1
Illegible Information 1
Total Device Problems 6147

Recalls
Manufacturer Recall Class Date Posted
1 Encore Medical, Lp II Mar-08-2017
2 Encore Medical, Lp II Oct-30-2015
3 Enztec Limited II Jan-24-2020
4 Exactech, Inc. II Sep-10-2019
5 Greatbatch Medical I Nov-29-2016
6 Stryker Howmedica Osteonics Corp. II Oct-07-2016
7 Zimmer Biomet, Inc. II Feb-14-2018

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