• 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 pin, fixation, smooth
Regulation Description Smooth or threaded metallic bone fixation fastener.
Product CodeHTY
Regulation Number 888.3040
Device Class 2


Premarket Reviews
ManufacturerDecision
4WEB, INC.
  SUBSTANTIALLY EQUIVALENT 1
ADDITIVE ORTHOPAEDICS, LLC
  SUBSTANTIALLY EQUIVALENT 1
ARTHREX, INC.
  SUBSTANTIALLY EQUIVALENT 3
IN2BONES SAS
  SUBSTANTIALLY EQUIVALENT 2
METRIC MEDICAL DEVICES, INC.
  SUBSTANTIALLY EQUIVALENT 1
NEWCLIP TECHNICS
  SUBSTANTIALLY EQUIVALENT 1
NOVASTEP
  SUBSTANTIALLY EQUIVALENT 1
ORTHOFIX
  SUBSTANTIALLY EQUIVALENT 1
ORTHOFIX SRL
  SUBSTANTIALLY EQUIVALENT 1
PARAGON 28
  SUBSTANTIALLY EQUIVALENT 1
PRECIFIT MEDICAL LTD
  SUBSTANTIALLY EQUIVALENT 1
SPINAL RESOURCES INC
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 3
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Adverse Event Without Identified Device or Use Problem 153
Break 119
Mechanical Jam 40
Fracture 27
Migration or Expulsion of Device 11
Material Twisted / Bent 9
Separation Failure 8
Bent 7
Device Operates Differently Than Expected 6
Material Fragmentation 6
Physical Resistance / Sticking 6
Patient Device Interaction Problem 5
Difficult to Insert 5
Difficult to Advance 4
Insufficient Information 4
Fitting Problem 4
Device-Device Incompatibility 4
Patient-Device Incompatibility 4
Appropriate Term/Code Not Available 4
Component Missing 3
Material Integrity Problem 3
Migration 3
Unintended Movement 3
Detachment of Device or device Component 3
Naturally Worn 3
Entrapment of Device 3
Shelf Life Exceeded 2
Failure to Align 2
Material Deformation 2
Failure to Advance 2
Product Quality Problem 2
Unstable 2
Shipping Damage or Problem 2
Use of Device Problem 2
No Display / Image 1
Material Puncture / Hole 1
Difficult to Open or Close 1
Activation Failure Including Expansion Failures 1
Electrical /Electronic Property Problem 1
Misassembled 1
Improper or Incorrect Procedure or Method 1
Tear, Rip or Hole in Device Packaging 1
Pin 1
Difficult to Remove 1
Device Operational Issue 1
Shaft break 1
Inadequacy of Device Shape and/or Size 1
Sticking 1
Failure to Power Up 1
Device Packaging Compromised 1
Material Protrusion / Extrusion 1
Device Slipped 1
Display or Visual Feedback Problem 1
Packaging Problem 1
Missing Value Reason 1
Flaked 1
Material Rupture 1
Device Damaged Prior to Use 1
Malposition of device 1
Device Disinfection Or Sterilization Issue 1
Total Device Problems 489

Recalls
Manufacturer Recall Class Date Posted
1 Amendia, Inc II Dec-22-2016
2 Biomet, Inc. II May-26-2016
3 Brasseler USA I Lp II Jan-29-2020
4 MicroAire Surgical Instruments, LLC II Mar-03-2017
5 Zimmer Biomet, Inc. II Jun-01-2018
6 Zimmer Biomet, Inc. II Oct-14-2016

-
-