Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
TPLC - Total Product Life Cycle
FDA Home
medical devices
databases
-
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
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
Back to Search Results
Device
cutter, wire
Product Code
HXZ
Regulation Number
888.4540
Device Class
1
MDR Year
MDR Reports
MDR Events
2016
33
33
2017
25
25
2018
26
26
2019
36
36
2020
24
24
2021
44
44
2022
37
37
2023
33
33
2024
13
13
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
156
156
Material Integrity Problem
29
29
Fracture
22
22
Failure to Cut
14
14
Dull, Blunt
12
12
Material Fragmentation
9
9
Material Deformation
7
7
Mechanical Problem
6
6
Device Operates Differently Than Expected
5
5
Device Inoperable
4
4
Component Missing
4
4
Contamination /Decontamination Problem
4
4
Crack
3
3
Mechanical Jam
3
3
Naturally Worn
3
3
Adverse Event Without Identified Device or Use Problem
2
2
Activation, Positioning or Separation Problem
2
2
Flaked
2
2
Corroded
1
1
Delivered as Unsterile Product
1
1
Device Slipped
1
1
Material Frayed
1
1
Delamination
1
1
Defective Device
1
1
Bent
1
1
Detachment of Device or Device Component
1
1
Material Twisted/Bent
1
1
Device Operational Issue
1
1
Device-Device Incompatibility
1
1
Difficult to Open or Close
1
1
Compatibility Problem
1
1
Packaging Problem
1
1
No Apparent Adverse Event
1
1
Insufficient Information
1
1
Physical Resistance/Sticking
1
1
Device Fell
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
119
119
No Known Impact Or Consequence To Patient
46
46
No Consequences Or Impact To Patient
43
43
No Patient Involvement
37
37
No Code Available
12
12
Foreign Body In Patient
7
7
Insufficient Information
6
6
No Information
5
5
Device Embedded In Tissue or Plaque
2
2
Alteration In Body Temperature
1
1
Brain Injury
1
1
Spinal Cord Injury
1
1
Blood Loss
1
1
Hemorrhage/Bleeding
1
1
Laceration(s)
1
1
Tissue Damage
1
1
Weakness
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Zimmer Biomet, Inc.
II
Dec-22-2020
-
-