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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
Mechanical Problem 16
Device Operates Differently Than Expected 16
Difficult to Remove 16
Physical Resistance / Sticking 15
Dull, Blunt 14
Adverse Event Without Identified Device or Use Problem 14
Bent 13
Fitting Problem 11
Unintended Movement 10
Detachment Of Device Component 9
Sticking 7
Entrapment of Device 7
Device Damaged by Another Device 6
Device Reprocessing Problem 6
Corroded 6
Device Issue 5
Device Damaged Prior to Use 4
Positioning Problem 4
Material Discolored 4
Degraded 4
Device Dislodged or Dislocated 4
Tip 3
No Apparent Adverse Event 3
Material Split, Cut or Torn 3
Use of Device Problem 3
Delivered as Unsterile Product 3
Defective Component 3
Problem with Sterilization 3
Defective Device 3
Separation Problem 3
Separation Failure 3
Failure to Clean Adequately 2
Device Or Device Fragments Location Unknown 2
Device Slipped 2
Material Distortion 2
Difficult to Insert 2
Material Rupture 2
Flaked 2
Component Falling 2
Device Operational Issue 2
Material Integrity Problem 2
Failure To Adhere Or Bond 2
Device Difficult to Maintain 2
Device Difficult to Setup or Prepare 2
Retraction Problem 1
Structural Problem 1
Delamination 1
Screw 1
Particulates 1
Circuit Breaker 1
Explosion 1
Device Fell 1
Missing Information 1
Compatibility Problem 1
Misconnection 1
Device Inoperable 1
Illegible Information 1
Migration or Expulsion of Device 1
Pitted 1
Material Disintegration 1
Burst Container or Vessel 1
Disconnection 1
Imprecision 1
Device Disinfection Or Sterilization Issue 1
Failure to Align 1
Blocked Connection 1
Failure to Discharge 1
Fluid Leak 1
Peeled / Delaminated 1
Loss of Osseointegration 1
Dent in Material 1
Material Protrusion / Extrusion 1
Locking Mechanism 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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