• 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 table, surgical with orthopedic accessories, manual
Regulation Description Manual operating table and accessories and manual operating chair and accessories.
Product CodeJEB
Regulation Number 878.4950
Device Class 1

MDR Year MDR Reports MDR Events
2015 2 2
2016 2 2
2017 3 3
2018 3 3
2019 1 1
2020 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Unintended Movement 2 2
Break 2 2
Crack 1 1
Patient-Device Incompatibility 1 1
Detachment of Device or Device Component 1 1
Device Operates Differently Than Expected 1 1
Mechanical Jam 1 1
Noise, Audible 1 1
Controller 1 1
Table 1 1
Switch, Push Button 1 1
Loose or Intermittent Connection 1 1
Self-Activation or Keying 1 1
Device Inoperable 1 1
Malposition of Device 1 1
Positioning Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 6 6
No Information 3 3
Pain 1 1
Injury 1 1
Fall 1 1
No Consequences Or Impact To Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Allen Medical Systems II Feb-20-2018
2 Schaerer Medical USA Inc II Nov-08-2016
3 Zimmer Biomet, Inc. II Feb-28-2018
4 Zimmer Surgical Inc II May-28-2019
-
-