• 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 Back To Search Results
Device passer
Regulation Description Orthopedic manual surgical instrument.
Product CodeHWQ
Regulation Number 888.4540
Device Class 1


Premarket Reviews
ManufacturerDecision
3M COMPANY
  SUBSTANTIALLY EQUIVALENT 1
MITEK
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Tip breakage 8
Break 7
Material fragmentation 4
Unknown (for use when the device problem is not known) 4
Device, or device fragments remain in patient 2
Detachment of device component 2
No Information 2
Device or device fragments location unknown 1
Device handling issue 1
Deployment issue 1
Difficult to open or close 1
No Known Device Problem 1
Total Device Problems 34

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 1 0 0 1 2 1 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Biomet, Inc. II Dec-23-2015
2 Biomet, Inc. II Oct-09-2014
3 Biomet, Inc. II Jun-16-2014
4 Linvatec Corp. dba ConMed Linvatec II Aug-24-2010
5 Surgical Instrument Service And Savings, Inc. II Jul-01-2013

-
-