• 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 joint, temporomandibular, implant
Regulation Description Total temporomandibular joint prosthesis.
Definition Call for PMAs to be filed by 3/30/99 per 63 FR 71746 on 12/30/98 - Indicated for reconstruction of the temporomandibular joint.
Product CodeLZD
Regulation Number 872.3940
Device Class 3

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
0 0 2 2 0 4 0 3 1 0

Device Problems
No Known Device Problem 49
No Information 20
Migration of device or device component 18
Size incorrect for patient 7
Fitting problem 7
Patient-device incompatibility 4
Fracture 4
Implant, removal of 2
Osseointegration issue 2
Scratched material 2
Material discolored 2
Dislodged or dislocated 2
Device operates differently than expected 1
Device abrasion from instrument or another object 1
Break 1
Detachment of device component 1
Improper or incorrect procedure or method 1
Device remains implanted 1
Total Device Problems 125

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 0 0 0 0 2 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Biomet Microfixation, LLC II Dec-16-2014
2 Biomet Microfixation, LLC II Sep-02-2014

-
-