Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device instrument, surgical, sonic and accessory/attachment
Product CodeJDX
Regulation Number 888.4580
Device Class 2


Premarket Reviews
ManufacturerDecision
MECTRON S.P.A.
  SUBSTANTIALLY EQUIVALENT 1
MECTRON SPA
  SUBSTANTIALLY EQUIVALENT 1
MORLEY RESEARCH CONSORTIUM
  SUBSTANTIALLY EQUIVALENT 1
ORTHOSONICS, LTD.
  SUBSTANTIALLY EQUIVALENT 2
PIEZOSURGERY SRL
  SUBSTANTIALLY EQUIVALENT 1
SATALEC-ACTEON GROUP
  SUBSTANTIALLY EQUIVALENT 1
SATELEC
  SUBSTANTIALLY EQUIVALENT 1
SMTP TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 16 16
2015 6 6
2016 4 4
2017 8 8
2018 42 42
2019 34 34
2020 11 11
2021 7 7
2022 10 10
2023 5 5
2024 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Electrical /Electronic Property Problem 42 42
Break 21 21
Fracture 19 19
Device Inoperable 13 13
Material Integrity Problem 11 11
Mechanical Problem 11 11
Overheating of Device 6 6
Defective Component 3 3
Device Stops Intermittently 3 3
Device Operates Differently Than Expected 3 3
Device Sensing Problem 2 2
Loss of Power 2 2
Difficult to Remove 2 2
Energy Output Problem 2 2
Entrapment of Device 2 2
Fire 1 1
Detachment Of Device Component 1 1
Intermittent Continuity 1 1
Unintended Power Up 1 1
Disassembly 1 1
Sticking 1 1
Device Remains Activated 1 1
Failure to Calibrate 1 1
Defective Device 1 1
Device Displays Incorrect Message 1 1
Detachment of Device or Device Component 1 1
Device-Device Incompatibility 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Material Twisted/Bent 1 1
Mechanical Jam 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Packaging Problem 1 1
Temperature Problem 1 1
Unintended Movement 1 1
Insufficient Information 1 1
Noise, Audible 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 44 44
No Code Available 40 40
No Clinical Signs, Symptoms or Conditions 16 16
No Consequences Or Impact To Patient 13 13
No Information 11 11
Foreign Body In Patient 6 6
Device Embedded In Tissue or Plaque 5 5
No Patient Involvement 5 5
Oversedation 4 4
Pain 3 3
Insufficient Information 3 3
Discomfort 2 2
Burn, Thermal 1 1
Patient Problem/Medical Problem 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Zimmer Biomet, Inc. II Jul-12-2019
-
-