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 cutter, wire
Regulation Description Orthopedic manual surgical instrument.
Product CodeHXZ
Regulation Number 888.4540
Device Class 1

MDR Year MDR Reports MDR Events
2020 24 24
2021 44 44
2022 37 37
2023 33 33
2024 34 34
2025 14 14

Device Problems MDRs with this Device Problem Events in those MDRs
Break 112 112
Material Integrity Problem 31 31
Fracture 13 13
Failure to Cut 7 7
Mechanical Problem 5 5
Crack 5 5
Material Deformation 5 5
Contamination /Decontamination Problem 3 3
Material Fragmentation 3 3
Device Slipped 2 2
Activation, Positioning or Separation Problem 2 2
Material Twisted/Bent 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Detachment of Device or Device Component 2 2
Material Frayed 1 1
Device-Device Incompatibility 1 1
Compatibility Problem 1 1
Device Fell 1 1
No Apparent Adverse Event 1 1
Naturally Worn 1 1
Corroded 1 1
Flaked 1 1
Mechanical Jam 1 1
Dull, Blunt 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 146 146
No Consequences Or Impact To Patient 16 16
Insufficient Information 14 14
Foreign Body In Patient 6 6
No Known Impact Or Consequence To Patient 3 3
No Patient Involvement 3 3
No Code Available 1 1
Tissue Damage 1 1
Hemorrhage/Bleeding 1 1
Device Embedded In Tissue or Plaque 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Zimmer Biomet, Inc. II Dec-22-2020
-
-